Worldwide Market For in Vitro Diagnostic

Worldwide Mkt for IVD Tests 8th Edition
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CHAPTER ONE: EXECUTIVE SUMMARY ............................................................................ 1

Scope and Methodology ............................................................................................................................. 3
Size and Growth of the Market ................................................................................................................. 7
Market Trends, Positive and Negative .................................................................................................... 11
CHAPTER TWO: INTRODUCTION...................................................................................... 13

Report Design............................................................................................................................................ 14
Lab Medicine Disciplines and Applications ........................................................................................... 15
Market Analysis of IVD Market Segments ............................................................................................ 20
The Lure Of IVD New Majors And Entrants ..................................................................................... 24
Licenses and Collaboration Agreements ................................................................................................ 37
Test Services .............................................................................................................................................. 39
Top Suppliers and Niche Players ............................................................................................................ 44
Point of View ............................................................................................................................................. 49
CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS ............ 51

Background ............................................................................................................................................... 51
Population and Disease Demographics, Worldwide .............................................................................. 52
Chronic Diseases as a Market Driver ...................................................................................................... 54
Cancer ..................................................................................................................................................... 56
Diabetes................................................................................................................................................... 59
Allergy .................................................................................................................................................... 61
The BRIC Effect ..................................................................................................................................... 62
World Segments of the IVD Market and IVD Market Evolution ....................................................... 65
United States a country in flux .............................................................................................................. 68
RUO/IUO Issues ..................................................................................................................................... 69
The Patient Protection and Affordable Care Act ..................................................................................... 70
Accountable Care Organizations............................................................................................................. 72
LDT Oversight ........................................................................................................................................ 72
Accent on Preventative Care ................................................................................................................... 74
In Patient Bundling ................................................................................................................................. 75
Molecular Test Reimbursement .............................................................................................................. 76
Japan .......................................................................................................................................................... 79
Europe - effects of austerity ..................................................................................................................... 81
IVD Directive Update ............................................................................................................................. 87
China .......................................................................................................................................................... 88
India ........................................................................................................................................................... 91
Brazil .......................................................................................................................................................... 94
Russia ......................................................................................................................................................... 96
CHAPTER FOUR: TRENDS AND INNOVATION ................................................................ 101

Background ..............................................................................................................................................101
Looking To the East.................................................................................................................................101
Looking Past the Hospital ER.................................................................................................................106
Telemedicine and Home Care Trends....................................................................................................109
Commercialization of Novel Tests ..........................................................................................................111
EMR Update ............................................................................................................................................116
mHealth, Connectivity and Healthcare Efficiencies .............................................................................120
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CHAPTER FIVE: POINT-OF-CARE TESTS ...................................................................... 133

Overview ...................................................................................................................................................133
The Major POC Test Players .................................................................................................................137
Market Analysis .......................................................................................................................................140
Blood Glucose Self-Testing ...................................................................................................................143
Continuous Self Testing .........................................................................................................................145
Blood Glucose Testing by Professionals ................................................................................................148
Diabetes Testing Glycated Hemoglobin..............................................................................................149
The Genetics of Diabetes .......................................................................................................................151
The Commercial Outlook for POC Tests ..............................................................................................153
CHAPTER SIX: THE CORE LAB ...................................................................................... 155

Core Lab Overview..................................................................................................................................155
Overview of Chemistry Tests ..................................................................................................................160
Market Analysis .......................................................................................................................................161
Critical Care Analysis .............................................................................................................................165
Urinalysis ..................................................................................................................................................168
The Commercial Outlook for Chemistry Tests .....................................................................................170
CHAPTER SEVEN: IMMUNOASSAYS ................................................................................ 171

Overview of Immunoassays ....................................................................................................................171
Market Analysis: Leading Suppliers and Growth Potential ................................................................176
Immunoassay Test Segments Mature, Maturing and Emerging ....................................................180
Mature Assay Segment ..........................................................................................................................180
Thyroid Function....................................................................................................................................180
Therapeutic Drug Tests ..........................................................................................................................180
Anemia ...................................................................................................................................................181
Tox/DAU ...............................................................................................................................................181
Allergy ...................................................................................................................................................181
Maturing Immunoassays ........................................................................................................................183
Proteins ..................................................................................................................................................183
Growth Immunoassays ...........................................................................................................................183
Vitamin D...............................................................................................................................................184
Tumor Markers ......................................................................................................................................186
Cardiac Markers .....................................................................................................................................190
Autoimmune ..........................................................................................................................................193
Diabetes..................................................................................................................................................198
Miscellaneous.........................................................................................................................................201
Point-of-care OTC and Professional Use ...............................................................................................203
Patient Self-tests (OTC) .........................................................................................................................206
Pregnancy Testing ..................................................................................................................................207
Cardiovascular Diagnostics ....................................................................................................................208
Drugs of Abuse/Therapeutic Drug Monitoring ......................................................................................209
The Commercial Outlook for Immunoassays .......................................................................................211
CHAPTER EIGHT: MOLECULAR ASSAYS ....................................................................... 213

Overview ...................................................................................................................................................213
Worldwide Opportunities for Molecular Tests .....................................................................................214
Molecular Test User Markets .................................................................................................................219
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Next Generation Sequencing...................................................................................................................221
Mass Spectrometry ..................................................................................................................................225
Molecular Technologies and Players......................................................................................................228
Market Analysis .......................................................................................................................................232
Oncology ................................................................................................................................................233
Inherited Diseases ..................................................................................................................................240
Prenatal Chromosome Analysis .............................................................................................................246
Tissue Typing .........................................................................................................................................253
The Commercial Outlook for Molecular Tests .....................................................................................256
CHAPTER NINE: HEMATOLOGY..................................................................................... 259

Overview ...................................................................................................................................................259
Automation and IT ..................................................................................................................................260
Digital Evolution ......................................................................................................................................261
Decentralized Hematology Testing.........................................................................................................263
Market Analysis: Leading Suppliers......................................................................................................266
The Commercial Outlook for Hematology Tests ..................................................................................269
CHAPTER TEN: COAGULATION...................................................................................... 271

Overview of Coagulation and Immunohematology Tests ...................................................................271
Genetics and Personalized Medicine ......................................................................................................273
Warfarin .................................................................................................................................................273
Plavix .....................................................................................................................................................276
Market Analysis .......................................................................................................................................280
Lab-based Testing ..................................................................................................................................281
Genetic Markers of Hypercoagulopathies ..............................................................................................283
Decentralized Coagulation testing Professional Use ...........................................................................285
Decentralized Coagulation testing OTC..............................................................................................288
Platelet Testing .......................................................................................................................................288
Leading Suppliers ..................................................................................................................................289
The Commercial Market for Coagulation Tests ...................................................................................291
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY.................................................. 293

Overview ...................................................................................................................................................293
Special Topics ...........................................................................................................................................294
Antimicrobial Drug Resistance ..............................................................................................................294
Genome Sequencing and Mass Spectrometry ........................................................................................296
Sepsis Serology ......................................................................................................................................302
Market Analysis .......................................................................................................................................304
Supplies ..................................................................................................................................................306
Chromogenic Media ...............................................................................................................................307
Microbial Identification and Antimicrobial Sensitivity Tests ................................................................309
Liquid Microbiology ..............................................................................................................................311
Blood Culture .........................................................................................................................................315
Rapid Tests.............................................................................................................................................317
Immunoassays lab based .....................................................................................................................318
Immunoassays rapid ............................................................................................................................323
Molecular Tests ......................................................................................................................................326
The Commercial Outlook for Microbiology / Virology Tests .............................................................333
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CHAPTER TWELVE: BLOOD BANKING SERVICES ......................................................... 337

Overview ...................................................................................................................................................337
Blood Management Are Routine Transfusions Good Medicine? .....................................................341
Blood Tracking ......................................................................................................................................343
Chagas Disease ......................................................................................................................................344
Platelet Safety ........................................................................................................................................345
Market Analysis .......................................................................................................................................347
Blood Grouping......................................................................................................................................348
Immunoassays ........................................................................................................................................353
Nucleic Acid Testing (NAT) Continues to Grow ..................................................................................354
The Commercial Outlook for Blood Banking .......................................................................................357
CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY .................................................... 361

Overview ...................................................................................................................................................361
Special Topics ...........................................................................................................................................363
Companies Expand With Test Services .................................................................................................363
Market Analysis .......................................................................................................................................367
Histology/Cytology ................................................................................................................................368
Traditional Stains ...................................................................................................................................373
Pap and HPV Testing .............................................................................................................................373
Immunohistochemistry and In Situ hybridization ..................................................................................378
Pharmacodiagnostic Histology ...............................................................................................................379
Digital Imaging ......................................................................................................................................385
Tissue Microarrays .................................................................................................................................388
Circulating Tumor Cells .........................................................................................................................390
Chromosome Analysis ...........................................................................................................................393
Flow Cytometry .....................................................................................................................................396
The Commercial Outlook for Histology and Cytology Tests ...............................................................399
CHAPTER FOURTEEN: COMPANY PROFILES, THE TOP TIER ....................................... 401

Abbott Diagnostics ...................................................................................................................................402
Recent Revenue History .........................................................................................................................403
Core Lab.................................................................................................................................................404
Infectious Diseases .................................................................................................................................406
HLA .......................................................................................................................................................407
Hematology ............................................................................................................................................407
Molecular Histology ..............................................................................................................................407
Molecular Diagnostics ...........................................................................................................................409
Molecular Tests for Infectious Diseases ................................................................................................411
Molecular Tests for HAI ........................................................................................................................413
Abbott Diabetes Care .............................................................................................................................413
Blood Bank ............................................................................................................................................415
Point of Care ..........................................................................................................................................416
Microbiology..........................................................................................................................................417
Molecular Sample Prep ..........................................................................................................................417
Information Technology.........................................................................................................................418
Biowar ....................................................................................................................................................418
Alere ..........................................................................................................................................................419
Recent Revenue History: $ million (* estimated) ..................................................................................419
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Key Comment ........................................................................................................................................419
Point of Care ..........................................................................................................................................421
Arkray ......................................................................................................................................................423
Key Comment. .......................................................................................................................................423
Beckman Coulter Inc...............................................................................................................................426
Recent Revenue History: estimated .....................................................................................................426
Key Comment ........................................................................................................................................427
Hematology ............................................................................................................................................428
Core Lab.................................................................................................................................................429
Immunoassays ........................................................................................................................................429
Coagulation ............................................................................................................................................431
Automation ............................................................................................................................................432
Flow Cytometry .....................................................................................................................................432
Molecular ...............................................................................................................................................433
Becton, Dickinson and Company (BD) ..................................................................................................436
Key Comment. .......................................................................................................................................437
Histology ................................................................................................................................................437
Molecular ...............................................................................................................................................438
Molecular Microbiology ........................................................................................................................439
Microbiology Automation ......................................................................................................................441
Immunoassays ........................................................................................................................................441
Microbiology..........................................................................................................................................442
Blood Culture .........................................................................................................................................443
Mass Spectrometry .................................................................................................................................443
Flow Cytometry .....................................................................................................................................444
BD Vacutainer Blood Collection Products (Preanalytical Systems) ......................................................445
bioMrieux Inc. ........................................................................................................................................447
Recent Revenue History: estimated .....................................................................................................447
Key Comment ........................................................................................................................................448
Microbiology..........................................................................................................................................448
Blood Culture .........................................................................................................................................450
Blood Banks ...........................................................................................................................................450
Molecular Oncology ..............................................................................................................................451
Molecular Microbiology ........................................................................................................................453
Immunoassays ........................................................................................................................................454
Bio-Rad Laboratories Inc. ......................................................................................................................455
Recent Revenue History: ......................................................................................................................455
Key Comment ........................................................................................................................................455
HIV ........................................................................................................................................................456
Molecular ...............................................................................................................................................456
Immunoassays ........................................................................................................................................456
Blood Bank ............................................................................................................................................457
Research .................................................................................................................................................458
Danaher Corporation ..............................................................................................................................459
Recent Revenue History .......................................................................................................................459
AB Sciex ................................................................................................................................................460
Leica .......................................................................................................................................................460
Gen-Probe Inc. .........................................................................................................................................463
Recent Revenue History (in millions) ....................................................................................................463
Key Comment . .....................................................................................................................................463
The acquisitions include:........................................................................................................................463
Expansion ...............................................................................................................................................464
Molecular Assays ...................................................................................................................................465
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HPV........................................................................................................................................................466
Transplant/HLA testing ..........................................................................................................................467
Blood Bank ............................................................................................................................................468
Oncology ................................................................................................................................................469
Hologic, Inc...............................................................................................................................................471
Key Comment ........................................................................................................................................471
Histology ................................................................................................................................................471
HPV........................................................................................................................................................472
Horiba Medical ........................................................................................................................................473
Recent Revenue History:........................................................................................................................473
Key Comment. .......................................................................................................................................473
Instrumentation Laboratory (IL) ...........................................................................................................475
Recent Revenue History (estimated) ......................................................................................................475
Key Comment. .......................................................................................................................................475
Coagulation ............................................................................................................................................476
Critical Care ...........................................................................................................................................477
Ortho Clinical Diagnostics ......................................................................................................................478
Key Comment. .......................................................................................................................................478
Blood Bank ............................................................................................................................................479
Core Lab.................................................................................................................................................479
Immunoassays ........................................................................................................................................481
Molecular ...............................................................................................................................................481
QIAGEN N.V. ..........................................................................................................................................482
Key Comment ........................................................................................................................................482
Histology ................................................................................................................................................485
Oncology ................................................................................................................................................487
TB 490
HPV........................................................................................................................................................490
HLA .......................................................................................................................................................490
Automation for the Future......................................................................................................................491
Point of Care ..........................................................................................................................................492
Radiometer A/S ........................................................................................................................................494
Key Comment ........................................................................................................................................494
Immunoassays ........................................................................................................................................495
Roche Diagnostics ....................................................................................................................................497
Key Comment ........................................................................................................................................498
PCR ........................................................................................................................................................498
Molecular Infectious Diseases ...............................................................................................................499
Viral Load ..............................................................................................................................................500
HPV........................................................................................................................................................500
Companion Tests....................................................................................................................................501
Core Lab.................................................................................................................................................503
Immunoassays ........................................................................................................................................505
Diabetes Care .........................................................................................................................................505
Point-of-Care..........................................................................................................................................507
Coagulation ............................................................................................................................................508
Histology ................................................................................................................................................509
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Blood Bank ............................................................................................................................................510
Sequencing .............................................................................................................................................510
Siemens Healthcare Diagnostics .............................................................................................................514
Key Comment. .......................................................................................................................................514
Core Lab.................................................................................................................................................515
Point of Care ..........................................................................................................................................517
Critical Care ...........................................................................................................................................517
Histology ................................................................................................................................................518
Molecular ...............................................................................................................................................519
Microbiology..........................................................................................................................................520
Allergy ...................................................................................................................................................520
Coagulation ............................................................................................................................................521
Immunoassays ........................................................................................................................................521
Urinalysis ...............................................................................................................................................524
Connectivity ...........................................................................................................................................524
Sysmex Corporation ................................................................................................................................526
Key Comment ........................................................................................................................................526
Expansion ...............................................................................................................................................527
Hematology ............................................................................................................................................527
Urinalysis ...............................................................................................................................................529
Self-Testing Devices ..............................................................................................................................529
Molecular ...............................................................................................................................................529
Thermo Fisher Scientific Inc. .................................................................................................................531
Recent Revenue History :......................................................................................................................531
Key Comment. .......................................................................................................................................531
Core Lab.................................................................................................................................................532
Microbiology..........................................................................................................................................533
Point of Care ..........................................................................................................................................534
Specialty Diagnostics .............................................................................................................................534
CHAPTER FIFTEEN: COMPANY PROFILES, THE SECOND TIER .................................... 535

Affymetrix, Inc. ........................................................................................................................................536
Recent Revenue History: (product sales, $ million) ...............................................................................536
Agilent Technologies Inc. ........................................................................................................................541
Axis-Shield plc..........................................................................................................................................545
Recent Revenue History (in millions) ....................................................................................................545
Bruker BioSciences Corporation ............................................................................................................549
Microbiology..........................................................................................................................................549
Histology ................................................................................................................................................552
Celera Diagnostics ...................................................................................................................................553
Cepheid .....................................................................................................................................................557
Recent Revenue History: ......................................................................................................................557
Personalized Medicine ...........................................................................................................................559
China Medical Technologies ...................................................................................................................561
Recent Revenue History: .....................................................................................................................561
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Dako A/S ...................................................................................................................................................564
Companion Diagnostics .........................................................................................................................567
DiaSorin S.p.A..........................................................................................................................................569
Molecular ...............................................................................................................................................571
Eiken Chemical Co., Ltd .........................................................................................................................572
ELITech Group........................................................................................................................................574
Fujirebio Diagnostics, Inc. ......................................................................................................................576
General Electric - GE Healthcare ..........................................................................................................580
Cell Imaging...........................................................................................................................................581
Molecular Sequencing............................................................................................................................582
EMR .......................................................................................................................................................583
Grifols, S.A. ..............................................................................................................................................585
Illumina Inc. .............................................................................................................................................587
Microbiology..........................................................................................................................................591
CLIA Lab Service ..................................................................................................................................591
Research .................................................................................................................................................592
IRIS International, Inc. ...........................................................................................................................594
Urinalysis ...............................................................................................................................................595
Hematology ............................................................................................................................................596
Molecular ...............................................................................................................................................596
Cytology .................................................................................................................................................598
Life Technologies .....................................................................................................................................600
Personalized Medicine ...........................................................................................................................602
Arrays .....................................................................................................................................................605
Sample Preparation ................................................................................................................................605
IVD Company Deals ..............................................................................................................................605
International Presence ............................................................................................................................607
Luminex Corporation ..............................................................................................................................609
IVD Expansion .......................................................................................................................................610
Automation ............................................................................................................................................613
Magellan Biosciences ...............................................................................................................................615
A. Menarini Diagnostics ..........................................................................................................................617
Mindray Bio-Medical Electronics Co., Ltd ...........................................................................................619
Nanosphere, Inc. ......................................................................................................................................621
Immunoassays ........................................................................................................................................623
Nova Biomedical ......................................................................................................................................625
Diabetes..................................................................................................................................................626
Novartis Diagnostics ................................................................................................................................629
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Blood Bank ............................................................................................................................................629
Blood Grouping......................................................................................................................................630
Molecular ...............................................................................................................................................631
Companion Tests....................................................................................................................................632
PerkinElmer, Inc. ....................................................................................................................................634
Prenatal and Neonatal Screening............................................................................................................634
Molecular and Sequencing Diagnostics .................................................................................................639
Cord Blood .............................................................................................................................................640
Immunoassays ........................................................................................................................................641
Human Health Research .........................................................................................................................642
Phadia AB.................................................................................................................................................644
Allergy ...................................................................................................................................................645
Phadia Immunology Reference Laboratory ...........................................................................................646
Autoimmune ..........................................................................................................................................646
Pharmaceutical Services.........................................................................................................................647
Quidel Corporation .................................................................................................................................648
Immunoassays ........................................................................................................................................649
Molecular Business ................................................................................................................................649
Randox Laboratories Ltd........................................................................................................................651
Core Lab.................................................................................................................................................652
Point of Care ..........................................................................................................................................654
Quality Control ......................................................................................................................................654
Sequenom .................................................................................................................................................655
Genetic Analysis Products .....................................................................................................................655
Sequenom Center for Molecular Medicine ............................................................................................657
Tosoh Corporation ..................................................................................................................................660
Immunoassays ........................................................................................................................................661
Transasia Bio-Medicals Ltd. ...................................................................................................................663
Trinity Biotech plc ...................................................................................................................................665
Point of Care ..........................................................................................................................................667
Ventana Medical Systems Inc. ................................................................................................................668
Veridex, LLC ...........................................................................................................................................674
Wako Pure Chemical Industries, Ltd. ...................................................................................................677
Werfen Group S.A. ..................................................................................................................................679
CHAPTER SIXTEEN: COMPANY PROFILES, THE THIRD TIER ....................................... 681

Arrayit Diagnostics Inc. ..........................................................................................................................682
Oncology ................................................................................................................................................683
Allergy ...................................................................................................................................................684
Astra Biotech GmbH ...............................................................................................................................685
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BG Medicine, Inc. ....................................................................................................................................687
Caliper Life Sciences ...............................................................................................................................690
Clinical Diagnostics ...............................................................................................................................690
Sequencing .............................................................................................................................................691
Life Sciences ..........................................................................................................................................693
Enzo Biochem Inc. ...................................................................................................................................695
Oncology ................................................................................................................................................696
Epigenomics AG ......................................................................................................................................698
Idaho Technology Inc. .............................................................................................................................701
Innogenetics NV .......................................................................................................................................704
International Technidyne Corp (ITC) ...................................................................................................705
Intrinsic Bioprobes Inc. ...........................................................................................................................707
Ivax Diagnostics Inc.................................................................................................................................709
Linkage Biosciences, Inc. ........................................................................................................................711
Molecular ...............................................................................................................................................714
Immunoassays ........................................................................................................................................715
Millipore EMD Millipore .....................................................................................................................717
Mitsubishi Chemical Medience Corporation ........................................................................................719
Nanosphere, Inc. ......................................................................................................................................721
OPTI Medical Systems ............................................................................................................................725
OptiGene Ltd ...........................................................................................................................................726
Polymedco, Inc. ........................................................................................................................................727
Philips .......................................................................................................................................................727
Radient Pharmaceuticals Corporation ..................................................................................................728
Seegene, Inc. .............................................................................................................................................730
SensiGen LLC ..........................................................................................................................................734
Spartan Bioscience Inc. ...........................................................................................................................735
TessArae, LLC .........................................................................................................................................737
Transgenomic, Inc. ..................................................................................................................................738
Lab Services ...........................................................................................................................................738
Diagnostic Tools Division......................................................................................................................740
TrimGen Genetic Technology.................................................................................................................744
TrovaGene, Inc. .......................................................................................................................................746
Prenatal ..................................................................................................................................................747
Vermillion Inc. .........................................................................................................................................748
Cardiac Markers .....................................................................................................................................749
Alzheimers Disease ..............................................................................................................................750
Cancer ....................................................................................................................................................750
CHAPTER SEVENTEEN: BLOOD BANK SPECIALISTS...................................................... 751

AbSorber AB ............................................................................................................................................751
Alien Technology .....................................................................................................................................753
AXO Science.............................................................................................................................................754
BIO-key International, Inc., ...................................................................................................................755
BloodCenter of Wisconsin .......................................................................................................................755
Cerus Corporation ...................................................................................................................................756
Core Dynamics .........................................................................................................................................758
CytoSorbents Corporation ......................................................................................................................759
Fenwal Inc. ...............................................................................................................................................760
GMS Biotech ............................................................................................................................................762
Haemonetics Corporation .......................................................................................................................763
Immucor, Inc. ...........................................................................................................................................765
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Immunetics Inc. .......................................................................................................................................766
Mediware Information Systems, Inc. .....................................................................................................768
Monash University ...................................................................................................................................769
Progenika Inc. ..........................................................................................................................................770
Quotient Biodiagnostics Inc. ...................................................................................................................772
Terumo Corporation ...............................................................................................................................773
Transfusion Management Services, Inc. (TxMS) ..................................................................................774
Verax Biomedical Inc. .............................................................................................................................775
CHAPTER EIGHTEEN: COAGULATION SPECIALISTS ..................................................... 777

Accumetrics ..............................................................................................................................................777
Diagnostica Stago .....................................................................................................................................780
Flow Cytometry .....................................................................................................................................781
Gamma Therapeutics, Inc.......................................................................................................................782
Microvisk Technologies ...........................................................................................................................784
Novo Nordisk............................................................................................................................................785
TCoag........................................................................................................................................................786
CHAPTER NINETEEN: DIABETES SPECIALISTS .............................................................. 787

AgaMatrix, Inc. ........................................................................................................................................787
ALR Technologies Inc. ............................................................................................................................789
Animas Corporation ................................................................................................................................790
Bayer Diabetes Care ................................................................................................................................791
Breath Testing at Home ..........................................................................................................................793
C8 MediSensors .......................................................................................................................................793
Cellnovo, Inc.............................................................................................................................................793
DexCom, Inc. ............................................................................................................................................795
Diagnostic Devices, Inc. ...........................................................................................................................798
Echo Therapeutics, Inc. ...........................................................................................................................799
Entra Health Systems ..............................................................................................................................800
Epinex Diagnostics, Inc. ..........................................................................................................................802
Glycomark ................................................................................................................................................803
GlySens Incorporated..............................................................................................................................804
HealthPartners .........................................................................................................................................805
Infopia Co Ltd ..........................................................................................................................................805
Insulet Corporation .................................................................................................................................807
Integrity Applications Ltd. .....................................................................................................................809
Lifescan Inc. .............................................................................................................................................811
Luminous Medical, Inc.: .........................................................................................................................814
Mayo Clinic ..............................................................................................................................................814
Medtronic Inc. ..........................................................................................................................................815
MicroCHIPS, Inc. ....................................................................................................................................818
Nipro Diagnostics/Home Diagnostics, Inc..............................................................................................819
OptiScan Biomedical Corporation .........................................................................................................820
OrSense Ltd..............................................................................................................................................821
Oxford Medical Diagnostics (OMD) ......................................................................................................822
PositiveID Corporation ...........................................................................................................................823
Glucose Monitoring ...............................................................................................................................824
Biowar Diagnostics ................................................................................................................................826
Solianis Monitoring AG ..........................................................................................................................826
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Tandem Diabetes Care, Inc.....................................................................................................................827
TelCare Inc...............................................................................................................................................828
VeraLight, Inc. .........................................................................................................................................829
CHAPTER TWENTY: HEMATOLOGY SPECIALISTS ......................................................... 831

Accuri Cytometers ...................................................................................................................................831
Burnet Institute ........................................................................................................................................833
CellaVision AB .........................................................................................................................................834
Constitution Medical, Inc. .......................................................................................................................836
Guava Technologies, Inc. ........................................................................................................................837
iCYt Mission Technology, Inc.................................................................................................................839
Horiba Medical ........................................................................................................................................839
NextSlide Imaging LLC ..........................................................................................................................840
Partec GmbH ...........................................................................................................................................841
PointCare Technologies...........................................................................................................................843
QBC Diagnostics, Inc...............................................................................................................................844
Zyomyx Inc...............................................................................................................................................846
CHAPTER TWENTY A: COMPANIES SPECIALIZING IN CIRCULATING

TUMOR CELLS ................................................................................................................ 849
ApoCell, Inc..............................................................................................................................................849
Clearbridge BioMedics ............................................................................................................................850
NaturalNano, Inc. ....................................................................................................................................851
On-Q-ity....................................................................................................................................................852
RareCyte, Inc. ..........................................................................................................................................853
ScreenCell .................................................................................................................................................854
CHAPTER TWENTY-ONE: HISTOLOGY SPECIALISTS................................................... 857

Advanced Cell Diagnostics ......................................................................................................................857
Almac Diagnostics....................................................................................................................................859
Aperio Technologies, Inc. ........................................................................................................................862
Biocare Medical, LLC .............................................................................................................................865
BioGenex Laboratories, Inc. ...................................................................................................................867
BioImagene ...............................................................................................................................................868
BioMarker Strategies ..............................................................................................................................870
Biomoda Inc. ............................................................................................................................................871
Cambridge Research & Instrumentation, Inc. ......................................................................................873
Cancer Genetics, Inc. ...............................................................................................................................874
Celerus Diagnostics..................................................................................................................................876
Cernostics, Inc. .........................................................................................................................................877
ChipDX, LLC ...........................................................................................................................................878
CytoCore, Inc. ..........................................................................................................................................882
Definiens ...................................................................................................................................................883
Foundation Medicine Inc. .......................................................................................................................885
Genetix Applied Imaging ........................................................................................................................887
HistoRx, Inc..............................................................................................................................................888
Holomic LLC............................................................................................................................................891
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Horizon Discovery Ltd ............................................................................................................................892
HTG Molecular Diagnostics ...................................................................................................................893
Ikonisys, Inc. ............................................................................................................................................895
Leica Microsystems .................................................................................................................................897
Sample Processing .................................................................................................................................897
Histological Analysis .............................................................................................................................897
APP ........................................................................................................................................................899
Massachusetts General Hospital.............................................................................................................900
Maven Biotechnologies histo ..................................................................................................................900
Metamark Genetics, Inc. .........................................................................................................................901
Milestone Medical ....................................................................................................................................902
Mitomics Inc. (formerly Genesis Genomics Inc.) ..................................................................................903
mtm laboratories AG...............................................................................................................................904
Novovision Inc ..........................................................................................................................................906
Olympus America ....................................................................................................................................906
Omnyx, LLC ............................................................................................................................................908
OvaGene Oncology Inc............................................................................................................................909
CHAPTER TWENTY-TWO: IMMUNOASSAY SPECIALISTS .............................................. 911

Abkine Pharmaceuticals .........................................................................................................................911
Acumen Pharmaceuticals, Inc. ...............................................................................................................912
Akers Biosciences, Inc. ............................................................................................................................913
Particle ImmunoFiltration Assay Technology .......................................................................................913
Breath Testing ........................................................................................................................................914
Arbor Vita Corporation ..........................................................................................................................915
ARK Diagnostics Inc. ..............................................................................................................................916
AspenBio Pharma, Inc.............................................................................................................................916
Associates of Cape Cod, Inc. (ACC) .......................................................................................................918
Augurex Life Sciences Corp....................................................................................................................918
Avantra Biosciences Corporation...........................................................................................................920
Autobio Group .........................................................................................................................................921
AXA Diagnostics Srl ................................................................................................................................922
Axela Biosensors, Inc. ..............................................................................................................................924
Binding Site ..............................................................................................................................................925
BioCurex, Inc. ..........................................................................................................................................927
Biomedical Diagnostics ............................................................................................................................928
Biomerica Inc. ..........................................................................................................................................930
Biophor Diagnostics .................................................................................................................................932
BioPorto A/S.............................................................................................................................................932
BioSystems International (BSI) ..............................................................................................................933
BRAHMS Aktiengesellschaft .............................................................................................................934
Cellmid Ltd. .............................................................................................................................................936
Corgenix Medical Corporation...............................................................................................................937
AspirinWorks .........................................................................................................................................937
Immunoassays ........................................................................................................................................938
Correlogic Systems, Inc. ..........................................................................................................................939
Critical Diagnostics..................................................................................................................................940
Cylex, Inc. .................................................................................................................................................941
diaDexus, Inc. ...........................................................................................................................................943
Diagnosticum Inc. ....................................................................................................................................944
Table of Contents
xiv
Diazyme Laboratories .............................................................................................................................944
Euroimmun AG .......................................................................................................................................946
GenBio ......................................................................................................................................................947
GlysBy .......................................................................................................................................................948
Gold Standard Diagnostics, Corporation ..............................................................................................949
HealthLinx Limited .................................................................................................................................950
Hycor Biomedical, Inc. ............................................................................................................................951
IMMCO Diagnostics, Inc. .......................................................................................................................952
Immunodiagn ...........................................................................................................................................953
ostic Systems Ltd. (IDS) ..........................................................................................................................953
Inova Diagnostics Inc. .............................................................................................................................954
Innovative Health Diagnostics ................................................................................................................955
Jeev Diagnostics .......................................................................................................................................955
LifeAssays AB ..........................................................................................................................................956
MabCure Inc. ...........................................................................................................................................957
Mediomics, LLC ......................................................................................................................................958
Miraculins Inc. .........................................................................................................................................959
Neogenix Oncology, Inc. ..........................................................................................................................961
Oasis Diagnostics Corporation ...............................................................................................................962
OJ-Bio Ltd. ...............................................................................................................................................963
OncoCyte Corp. .......................................................................................................................................964
OncoHealth Corp. ....................................................................................................................................964
Orgentec Diagnostika ..............................................................................................................................966
PrognostiX Inc. ........................................................................................................................................967
Protagen AG.............................................................................................................................................968
Proteomics International Pty Ltd. ..........................................................................................................969
Saladax Biomedical, Inc. .........................................................................................................................970
Sera Prognostics, Inc. ..............................................................................................................................971
Shanghai Kehua Bio-engineering ...........................................................................................................972
Shionogi Diagnostic .................................................................................................................................973
Sialix Inc. ..................................................................................................................................................974
SQI Diagnostics Inc. ................................................................................................................................975
Sword Diagnostics....................................................................................................................................976
Wistar Institute, The ...............................................................................................................................977
CHAPTER TWENTY-THREE: MICROBIOLOGY SPECIALISTS ......................................... 979

Accelr8 Technology Corporation ...........................................................................................................979
Advanced Biological Laboratories (ABL) .............................................................................................982
ABS Advanced Biomedical Systems (ABS .............................................................................................983
AdvanDx, Inc. ..........................................................................................................................................984
Akonni Biosystems Inc. ...........................................................................................................................986
Avioq, Inc. ................................................................................................................................................989
bioLytical Laboratories ...........................................................................................................................990
Biomagnetics Diagnostics Corporation ..................................................................................................991
BioVei Incorporated ................................................................................................................................993
BlackBio S.L. ............................................................................................................................................994
Calypte Biomedical Corporation ............................................................................................................995
Canon US Life Sciences ...........................................................................................................................996
CapitalBio Corporation...........................................................................................................................998
Catalysis Foundation for Health ............................................................................................................999
Cellestis Ltd ............................................................................................................................................1000
Table of Contents
xv
Chembio Diagnostic Systems, Inc.........................................................................................................1002
In Brazil ...............................................................................................................................................1005
Flu1005
China ....................................................................................................................................................1005
Ceeram S.A.S. ........................................................................................................................................1006
CHROMagar..........................................................................................................................................1007
Cooperative Diagnostics, LLC ..............................................................................................................1007
Copan Diagnostics Inc. ..........................................................................................................................1009
Swabs ...................................................................................................................................................1009
Lab Automation ...................................................................................................................................1010
Diagnostic HYBRIDS, Inc. (DHI) ........................................................................................................1012
Don Whitley Scientific ...........................................................................................................................1013
Dynacon Inc............................................................................................................................................1014
Enigma Diagnostics Limited .................................................................................................................1016
Focus Diagnostics, Inc. ..........................................................................................................................1019
Great Basin Scientific, Inc. ...................................................................................................................1020
Hain Lifescience GmbH ........................................................................................................................1021
Hardy Diagnostics..................................................................................................................................1024
Ibis Biosciences ......................................................................................................................................1025
Immunexpress Inc. ................................................................................................................................1027
Immuno-Mycologics (IMMY) ...............................................................................................................1028
InBios International, Inc. ......................................................................................................................1029
Ingen Biosciences ...................................................................................................................................1030
Innovotech Inc........................................................................................................................................1030
Intelligent Medical Devices, Inc. (IMDx) .............................................................................................1031
IQuum Inc. .............................................................................................................................................1032
Lab M .....................................................................................................................................................1033
MBio Diagnostics, Inc. ...........................................................................................................................1034
Miacom Diagnostics GmbH ..................................................................................................................1035
Micro Identification Technologies, Inc. (MIT) ....................................................................................1035
MicroBionetics, Inc. ...............................................................................................................................1036
Microgen Bioproducts Ltd. ...................................................................................................................1037
MicroPhage, Inc. ....................................................................................................................................1038
Mo Bio Laboratories..............................................................................................................................1039
Molecular Detection Inc. (MDI) ...........................................................................................................1040
Molzym GmbH & Co. KG ....................................................................................................................1041
MP Biomedicals LLC ............................................................................................................................1042
Myconostica ............................................................................................................................................1043
NanoLogix, Inc. ......................................................................................................................................1044
nanoMR Inc............................................................................................................................................1045
NetBio .....................................................................................................................................................1046
Next Dimension Technologies, Inc. ......................................................................................................1046
OraSure Technologies, Inc. ...................................................................................................................1047
Oxford Immunotec Ltd. ........................................................................................................................1049
Oxoid .......................................................................................................................................................1051
ID/AST.................................................................................................................................................1052
PathoGene ..............................................................................................................................................1053
Pathogenica ............................................................................................................................................1053
Preventx Limited ...................................................................................................................................1054
Phthisis Diagnostics Inc. ........................................................................................................................1055
Quantalife, Inc. ......................................................................................................................................1056
QuantuMDx Group Limited .................................................................................................................1057
QuickCheck Health Inc. ........................................................................................................................1058
R-Biopharm AG .....................................................................................................................................1059
Table of Contents
xvi
Renishaw Diagnostics Ltd .....................................................................................................................1060
Serosep Limited .....................................................................................................................................1062
Signature Mapping Medical Sciences, Inc. ..........................................................................................1062
SIRS-Lab ................................................................................................................................................1063
T2 Biosystems, Inc. ................................................................................................................................1064
CHAPTER TWENTY FOUR: MOLECULAR TEST SPECIALISTS ...................................... 1067

20/20 GeneSystems, Inc. ........................................................................................................................1067
Ahram Biosystems, Inc. .........................................................................................................................1069
Alacris Theranostics GmbH .................................................................................................................1070
Allegro Diagnostics Corp. .....................................................................................................................1071
Amoy Diagnostics Co. Ltd. ...................................................................................................................1072
Anagnostics Bioanalysis GmbH............................................................................................................1073
Applied BioCode, Inc.............................................................................................................................1074
ArcticDx Inc. ..........................................................................................................................................1076
Ariosa Diagnostics .................................................................................................................................1077
Asuragen, Inc. ........................................................................................................................................1078
Oncology ..............................................................................................................................................1078
Controls ................................................................................................................................................1081
Autogenomics Inc. .................................................................................................................................1082
Beijing Genome Institute (BGI)............................................................................................................1084
biOasis Technologies Inc. ......................................................................................................................1086
Biocartis SA ............................................................................................................................................1086
Biodesix, Inc. ..........................................................................................................................................1088
Biofortuna Ltd. ......................................................................................................................................1091
BioHelix Corporation ............................................................................................................................1092
Biomatrica, Inc.......................................................................................................................................1093
BioNanomatrix .......................................................................................................................................1094
BJS Biotechnologies ...............................................................................................................................1095
BlueGnome .............................................................................................................................................1096
CardioDx, Inc. ........................................................................................................................................1097
Curetis AG..............................................................................................................................................1099
DiaGenic ASA ........................................................................................................................................1100
DiagnoCure ............................................................................................................................................1101
Diagenode ...............................................................................................................................................1102
Dimerix Bioscience Pty Ltd...................................................................................................................1103
DNA Genotek Inc...................................................................................................................................1104
DxTerity Diagnostics Inc. ......................................................................................................................1105
EraGen Biosciences Inc. ........................................................................................................................1107
Eutropics Pharmaceuticals ...................................................................................................................1108
Everist Genomics ...................................................................................................................................1109
Evotec AG...............................................................................................................................................1110
EXACT Sciences Corporation ..............................................................................................................1111
Exosome Diagnostics Inc. ......................................................................................................................1113
Falcon Genomics Inc. ............................................................................................................................1114
Fluidigm Corporation ...........................................................................................................................1114
Prenatal ................................................................................................................................................1117
Fluoresentric, Inc. ..................................................................................................................................1118
Foundation Medicine. Inc. ....................................................................................................................1119
GeneNews Limited .................................................................................................................................1119
Genetic Technologies Limited...............................................................................................................1121
Table of Contents
xvii
GenMark Diagnostics Inc. ....................................................................................................................1123
GenoID Ltd. ...........................................................................................................................................1124
Genomic Expression, Inc.......................................................................................................................1125
Genomed AG ..........................................................................................................................................1126
Genomica S.A.U. ....................................................................................................................................1126
Genomind, LLC .....................................................................................................................................1127
Genorama Ltd. .......................................................................................................................................1129
GenturaDx ..............................................................................................................................................1130
GnuBIO, Inc. ..........................................................................................................................................1131
Great Basin Corporation ......................................................................................................................1132
Helicos BioSciences ................................................................................................................................1133
IncellDx, Inc. ..........................................................................................................................................1135
Inostics GmbH .......................................................................................................................................1136
Insight Genetics......................................................................................................................................1137
IntegenX Inc. ..........................................................................................................................................1139
Ipsogen SA ..............................................................................................................................................1141
LifeCodexx AG ......................................................................................................................................1143
LifeGen Technologies, LLC ..................................................................................................................1144
Linkage Biosciences, Inc. ......................................................................................................................1144
Lumora Ltd. ...........................................................................................................................................1145
Med BioGene, Inc. (MBI) ......................................................................................................................1146
Microsaic Systems plc............................................................................................................................1147
Multiplicom N.V. ...................................................................................................................................1147
NABsys, Inc. ...........................................................................................................................................1148
Nanostring Technologies, Inc................................................................................................................1149
NewGene .................................................................................................................................................1151
NIPD Genetics LTD...............................................................................................................................1153
NobleGen Biosciences ............................................................................................................................1153
Norgen Biotek Corp...............................................................................................................................1154
Nuvera Biosciences, Inc. ........................................................................................................................1155
OptiGene Ltd .........................................................................................................................................1156
Orion Genomics .....................................................................................................................................1157
Oxford Gene Technology ......................................................................................................................1159
Pharmigene.............................................................................................................................................1161
Population Diagnostics, Inc...................................................................................................................1162
PrimeraDx ..............................................................................................................................................1163
RainDance Technologies, Inc. ...............................................................................................................1163
Rheonix Inc. ...........................................................................................................................................1166
Sequenta, Inc. .........................................................................................................................................1167
Sirius Genomics .....................................................................................................................................1167
Skyline Diagnostics B.V.........................................................................................................................1168
Sony DADC Biosciences ........................................................................................................................1170
SpotOn Clinical Diagnostics Ltd ..........................................................................................................1172
Stratos Genomics Inc. ............................................................................................................................1173
SureGene, LLC ......................................................................................................................................1174
TcLand Expression SA ..........................................................................................................................1175
VolitionRx Limited ................................................................................................................................1175
WaferGen Biosystems, Inc. ...................................................................................................................1177
Waters Corporation...............................................................................................................................1179
Xagenic ...................................................................................................................................................1180
ZyGEM Corp. Ltd. ................................................................................................................................1181

Table of Contents
xviii
CHAPTER TWENTY-FIVE: POINT-OF-CARE SPECIALISTS .......................................... 1183

3M Health Care .....................................................................................................................................1183
Abaxis, Inc. .............................................................................................................................................1184
Acon Laboratories, Inc. .........................................................................................................................1186
Diabetes................................................................................................................................................1186
Other POC ............................................................................................................................................1187
Immunoassays ......................................................................................................................................1187
Alfa Scientific Designs, Inc....................................................................................................................1188
Augurix Diagnostics ..............................................................................................................................1189
BBInternational .....................................................................................................................................1190
CardioGenics Holdings Inc. ..................................................................................................................1190
CIC microGUNE ...................................................................................................................................1191
Claros Diagnostics, Inc. .........................................................................................................................1192
Clearbridge BioLoc Pte Ltd ..................................................................................................................1193
EKF Diagnostics Holdings plc ..............................................................................................................1194
Gentag Inc. .............................................................................................................................................1195
Hai Kang Life Corporation...................................................................................................................1196
Hema Diagnostic Systems (HDS)..........................................................................................................1197
Immunoassays ......................................................................................................................................1198
Helena Laboratories USA .....................................................................................................................1199
InstantLabs.............................................................................................................................................1200
Labonfoil Consortium ...........................................................................................................................1201
Metabolomx............................................................................................................................................1201
Micronics ................................................................................................................................................1203
MycroLab Pty Ltd. ................................................................................................................................1204
Ohmx Corporation ................................................................................................................................1204
OPKO Health, Inc. ................................................................................................................................1205
QuantRx Biomedical Corporation .......................................................................................................1206
Response Biomedical Corp. ..................................................................................................................1207
Rheonix, Inc. ..........................................................................................................................................1209
Samsung Electronics Co., Ltd. ..............................................................................................................1211
SensiVida Medical Technologies, Inc. ..................................................................................................1212
Sphere Medical Ltd. ..............................................................................................................................1213
SuperNova Diagnostics, Inc. .................................................................................................................1214
Systagenix ...............................................................................................................................................1215
T2 Biosystems, Inc. ................................................................................................................................1216
True Diagnostics, Inc. ............................................................................................................................1217
CHAPTER TWENTY-SIX: TEST SERVICE PROVIDERS .................................................. 1219

23andMe .................................................................................................................................................1219
Agendia BV ............................................................................................................................................1221
AltheaDx Diagnostics, Inc. ....................................................................................................................1225
Ambry Genetics .....................................................................................................................................1226
ARUP Laboratories ...............................................................................................................................1229
AssureRx Health ....................................................................................................................................1231
Atherotech Diagnostic Lab ...................................................................................................................1233
Atossa Genetics, Inc. ..............................................................................................................................1234
Avesthagen Limited ...............................................................................................................................1236
Biocept, Inc. ............................................................................................................................................1236
Biophysical Corporation .......................................................................................................................1240
BioReference Laboratories, Inc. (BRLI) .............................................................................................1241
Table of Contents
xix
GeneDx ................................................................................................................................................1242
BioServe ..................................................................................................................................................1243
bioTheranostics ......................................................................................................................................1244
Bostwick Laboratories...........................................................................................................................1246
Cancer Treatment Centers of America................................................................................................1247
CardioDx ................................................................................................................................................1247
Caris Life Sciences .................................................................................................................................1248
Castle Biosciences Inc. ...........................................................................................................................1250
Circadian Technologies .........................................................................................................................1251
CDx Diagnostics .....................................................................................................................................1252
Chronix Biomedical Inc. .......................................................................................................................1252
Clarient Inc. ...........................................................................................................................................1254
Clinical Reference Laboratory, Inc. (CRL) .........................................................................................1257
CombiMatrix Molecular Diagnostics, Inc. ..........................................................................................1258
Complete Genomics ...............................................................................................................................1260
Crescendo Bioscience, Inc. ....................................................................................................................1262
DeCode Genetics ....................................................................................................................................1263
Gene Variants.......................................................................................................................................1266
DermaGenoma, Inc................................................................................................................................1266
DiaTech Oncology..................................................................................................................................1268
Diatherix Laboratories Inc. ..................................................................................................................1269
Exagen Diagnostics, Inc.........................................................................................................................1271
Existence Genetics .................................................................................................................................1272
ExonHit Therapeutics ...........................................................................................................................1273
Gene Security Network Inc. (GSN) ......................................................................................................1274
Genelex Corporation .............................................................................................................................1275
Genetadi Biotech SL ..............................................................................................................................1276
Genetic Disease Foundation ..................................................................................................................1277
Genomas .................................................................................................................................................1278
Genomic Health, Inc. .............................................................................................................................1279
Sequencing ...........................................................................................................................................1282
Information Technology.......................................................................................................................1283
Genoptix Medical Laboratory ..............................................................................................................1284
GenoVive LLC .......................................................................................................................................1285
Genzyme Genetics..................................................................................................................................1286
Good Start Genetics, Inc. ......................................................................................................................1287
iGenix Inc. ..............................................................................................................................................1288
IntegraGen SA .......................................................................................................................................1289
Interleukin Genetics, Inc. ......................................................................................................................1291
Iverson Genetic Diagnostics, Inc. .........................................................................................................1293
Knome, Inc. ............................................................................................................................................1294
Lab21 Limited ........................................................................................................................................1296
Laboratory Corporation of America Holdings (LabCorp) ................................................................1299
Lineagen Inc. ..........................................................................................................................................1303
LipoScience, Inc. ....................................................................................................................................1304
Lumigenix ...............................................................................................................................................1305
Mayo Medical Laboratories..................................................................................................................1306
MDxHealth SA (formerly Oncomethylome Sciences) ........................................................................1308
Medco Health Solutions Inc. .................................................................................................................1311
Medical Diagnostic Laboratories, L.L.C. (MDL) ...............................................................................1314
Metabolon ...............................................................................................................................................1315
MinuteClinic...........................................................................................................................................1317
Mira Dx...................................................................................................................................................1319
Mitomics, Inc. .........................................................................................................................................1320
Table of Contents
xx
MolecularMD Corp. ..............................................................................................................................1321
Molecular Response ...............................................................................................................................1324
Myriad Genetics, Inc. ............................................................................................................................1325
Alliances ..............................................................................................................................................1325
Test Information ...................................................................................................................................1327
Patent Issues .........................................................................................................................................1328
Navigenics ...............................................................................................................................................1330
Oncimmune LLC ...................................................................................................................................1331
OncoPlexDx ............................................................................................................................................1331
OralDNA Labs .......................................................................................................................................1332
OvaGene Oncology, Inc.........................................................................................................................1333
Pacific Edge Biotechnology Limited (PEB) .........................................................................................1336
Partners HealthCare Center for Personalized Genetic Medicine (PCPGM) ..................................1337
Pathway Genomics.................................................................................................................................1339
Pathwork Diagnostics ............................................................................................................................1340
PersonaLabs ...........................................................................................................................................1342
PGXL Laboratories ...............................................................................................................................1343
Pinpoint Genomics, Inc. ........................................................................................................................1344
Power3 Medical Products, Inc. .............................................................................................................1345
Precision Therapeutics ..........................................................................................................................1346
Predictive Biosciences ............................................................................................................................1348
Prometheus Laboratories Inc. ..............................................................................................................1349
Patent Issues .........................................................................................................................................1351
Provista Diagnostics...............................................................................................................................1353
Psynomics Incorporated ........................................................................................................................1354
Quest Diagnostics ...................................................................................................................................1355
Infectious Diseases ...............................................................................................................................1357
Oncology ..............................................................................................................................................1357
Pharmacodiagnostics ............................................................................................................................1357
Neonatal ...............................................................................................................................................1358
Information Technology.......................................................................................................................1358
RedPath Integrated Pathology Inc. ......................................................................................................1359
Response Genetics, Inc. .........................................................................................................................1359
Ridge Diagnostics, Inc. svc ...................................................................................................................1362
Rosetta Genomics Ltd. ..........................................................................................................................1363
Rules-Based Medicine, Inc. (RBM) ......................................................................................................1366
Signal Genetics .......................................................................................................................................1367
Signature Diagnostics AG .....................................................................................................................1369
Sonic Healthcare ....................................................................................................................................1371
SpectraCell Laboratories, Inc. ..............................................................................................................1372
SureGene, LLC ......................................................................................................................................1374
SynapDx..................................................................................................................................................1375
Tethys Bioscience ...................................................................................................................................1375
Veracyte. Inc. .........................................................................................................................................1376
Verinata Health, Inc. .............................................................................................................................1378
CHAPTER TWENTY-SEVEN: COMPANY PROFILES: INFORMATION TECHNOLOGY

SPECIALISTS ................................................................................................................. 1379
Caradigm ................................................................................................................................................1379
Cerner Corporation ...............................................................................................................................1380
CLC bio ..................................................................................................................................................1381
Table of Contents
xxi
CollabRx .................................................................................................................................................1383
ConnectedHealth Pte. Ltd. ....................................................................................................................1384
Definiens .................................................................................................................................................1385
Dell Healthcare and Life Sciences ........................................................................................................1387
DNA Direct .............................................................................................................................................1388
EHealth2Share .......................................................................................................................................1389
Freescale Semiconductor.......................................................................................................................1389
GenomeQuest Inc. .................................................................................................................................1390
HolGenTech Inc. ....................................................................................................................................1391
Health Discovery Corporation (HDC) .................................................................................................1392
IDBS ........................................................................................................................................................1393
MediSapiens Ltd. ...................................................................................................................................1394
Personalis.........................................................................................................................................IT
..............................................................................................................................................................1395
Sciclips ....................................................................................................................................................1395
Selventa ...................................................................................................................................................1396
Sophic Systems Alliance ........................................................................................................................1397
Stanford University ...............................................................................................................................1397
University of Houston ............................................................................................................................1398
Wellpoint Inc. .........................................................................................................................................1399
Inc. Expression Diagnostics ...............................................................................................................1400
CHAPTER TWENTY-EIGHT: CORE LAB AND OTHER COMPANIES ............................. 1403

77 Elektronika Kft. ................................................................................................................................1403
Glucose ................................................................................................................................................1403
Urinalysis .............................................................................................................................................1404
Aetna .......................................................................................................................................................1405
AGD Biomedicals Pvt. Ltd ....................................................................................................................1405
Awareness Technology, Inc...................................................................................................................1406
Dana Farber Cancer Institute ..............................................................................................................1406
Daxor Corporation ................................................................................................................................1408
Diatron Group........................................................................................................................................1410
Intel Corporation ...................................................................................................................................1410
Mauna Kea Technologies ......................................................................................................................1411
Medco Health .........................................................................................................................................1412
MedTest DX, Inc. ...................................................................................................................................1413
Minias Globe Diagnostics S.r.l. .............................................................................................................1414
Proctor & Gamble .................................................................................................................................1414
QuantaLife, Inc. .....................................................................................................................................1415
Quanterix Corporation .........................................................................................................................1417
Quantimetrix Corp. ...............................................................................................................................1418
Scripps Health ........................................................................................................................................1419
Sekisui Diagnostics ................................................................................................................................1420
SeraCare Life Sciences, Inc...................................................................................................................1420
Seventh Sense Biosystems, Inc. .............................................................................................................1422
University of Michigan ..........................................................................................................................1423
Veterans Administration Health ..........................................................................................................1424
Walgreens ...............................................................................................................................................1425
Walmart..................................................................................................................................................1426

Table of Contents
xxii
L
CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Exchange Rate Fluctuations, 20062011 ................................................................. 5
Figure 1-1: World IVD Market, 2011 and 2016 ........................................................................ 8
Table 1-1: Worldwide In Vitro Diagnostic Sales by market segment 2011-2016 ................... 9
CHAPTER TWO: INTRODUCTION

Table 2-1: Worldwide In Vitro Diagnostic Sales by Product
Market 2011-2016, .............................................................................................................. 20
Figure 2-1: Worldwide In Vitro Diagnostic Sales by Segment, 2011 .................................... 23
Table 2-2: Selected New Entrants and Market Expansion Actions, 2011 ............................ 25
Table 2-3: Selected Diagnostics Industry New Entrants 2010-2011 ...................................... 32
Table 2-4: Selected Diagnostics Industry Acquisitions 2010-2011 ........................................ 35
Table 2-5: Selected Diagnostics Industry Collaboration and Distribution Agreements
2010-2011 ................................................................................................................................. 38
Table 2-6: Selected Test Services, sales 2009-2011 ................................................................. 39
Table 2-7: Lab Market Statistics, Worldwide, 2011 ............................................................... 40
Table 2-8: Revenues For A Selection Of Reference Labs, Worldwide, 2011 ...................... 41
Table 2-9: Selected CLIA-certified labs established in 2011.................................................. 43
Table 2-10: Revenues of Selected IVD Companies, 2007-2009 .............................................. 45
Table 2-11: Revenues of Selected Niche Players, 2009-2011 .................................................. 48
CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

Table 3-1: Selected Disease Statistics, Worldwide, as at July 2012 ....................................... 54
Table 3-2: Elderly Support Ratio in Selected Countries (2050) ............................................ 55
Table 3-3: Available Market Data, 2010 .................................................................................. 63
Table 3-4: BRIC Healthcare Infrastructure Capacity ........................................................... 64
Table 3-5: Worldwide In Vitro Diagnostic Reagent Sales by
Country/Region 2011-2016, ($ million) ................................................................................ 66
Table 3-6: European Union IVD Sales by Country 2010 ....................................................... 85
Table 3-7: Key Drivers for Healthcare in India ...................................................................... 93
CHAPTER FOUR: TRENDS AND INNOVATION

Table 4-1: World Market for Telehealth, Number of subscribers ...................................... 111
Table 4-2: Smartphone Use Among Physician Specialties, Percent .................................... 122
Table 4-3: Selected Phone-Based IVD Systems ..................................................................... 124
Table 4-4: Selected Professional Use Apps ............................................................................ 131
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xxiii
CHAPTER FIVE: POINT-OF-CARE TESTS

Table 5-1: POC Sales by Test Category, worldwide 2011-2016 (Sales $ millions) ............ 135
Figure 5-1: Professional POC Market ................................................................................... 136
Figure 5-2: OTC Point of Care Market ................................................................................. 137
Table 5-2: POC Test Revenues of Selected IVD Companies, ($ million), estimated ......... 138
Table 5-3: World Glucose Monitoring Sales, by Company, 2009-2011 .............................. 142
Table 5-4: Selected Data Management Enabled Glucose Monitors, 2011 .......................... 144
Table 5-5: Selected noninvasive glucose monitoring devices ............................................... 145
Table 5-6: Selected Continuous BGM Sales, 2011 ................................................................ 146
Table 5-7: Selected continuous blood glucose system developments, 2011 ......................... 147
Table 5-8: Selected POC HbA1c Devices ............................................................................... 151
CHAPTER SIX: THE CORE LAB

Table 6-1: Clinical Chemistry/Immunoassay Sales, 2011-2016 ($ million) ........................ 157
Figure 6-1: Core Lab Market, 2011 and 2016 ....................................................................... 158
Table 6-2: Core Lab Sales of the Top Five Manufacturers, 2009-2011, ($ million)* ......... 159
Table 6-3: Worldwide Clinical Chemistry Sales by Test Category 2011-2016................... 161
Figure 6-1: Clinical Chemistry Market ................................................................................. 162
Table 6-4: Selected New Core Lab Analyzers ....................................................................... 165
Table 6-5: Selected Critical Care Analysis Innovations, 2010-2011 .................................... 167
Figure 6-3: Urinalysis Market, 2011 and 2016 ...................................................................... 169
Table 6-8: Selected Urinalysis Innovations, 2010-2011 ........................................................ 170
CHAPTER SEVEN: IMMUNOASSAYS

Table 7-1: Selected Immunoassays on Core Lab Instruments ............................................ 173
Table 7-2: Selected New Immunoassay Platforms, 2011 ...................................................... 175
Table 7-3: Worldwide Lab-Based Immunoassay Sales by Analyte Type 2011-2016 ......... 177
Table 7-4: Revenue History of Leading Immunoassay Vendors, 2007-2011 ...................... 178
Table 7-5: Selected Tumor Marker Innovations, 2008-2011 ............................................... 189
Table 7-6: Selected Cardiac Marker Innovations, 2011 ....................................................... 193
Table 7-7: Selected Autoimmune Immunoassay Innovations, 2011 .................................... 197
Table 7-8: Selected Immunoassay Innovations, 2011 ........................................................... 202
Table 7-9: POC Immunoassay Test Sales by Test Category 2010-2011 ............................ 206
Table 7-11: Selected Professional POC Test Innovations, 2011 .......................................... 211

Table of Contents
xxiv
CHAPTER EIGHT: MOLECULAR ASSAYS

Table 8-1: Market Penetration Of Clinical Molecular Diagnostics,
By Geographic Area, 2011-2016 .......................................................................................... 217
Table 8-2: Selected Mass Specrometry Clinical Lab Applications...................................... 227
Table 8-3: Molecular Test Revenues Of Selected IVD Vendors, 2009-2011 ....................... 228
Table 8-4: Selected Nucleic Acid Testing Platforms ............................................................. 231
Table 8-5: Worldwide Molecular Test Sales By Type, $Million 2011-2016........................ 233
Table 8-6: Selected Molecular Tumor Marker Test Innovations ........................................ 235
Table 8-7: Most Frequently Requested Genetic Tests .......................................................... 241
Table 8-8: Selected Molecular Tests For Prenatal Analysis ................................................ 250
Table 8-9: Selected HLA Typing Tests .................................................................................. 256
CHAPTER NINE: HEMATOLOGY

Table 9-1: Selected Hematology Innovations, 2011 .............................................................. 263
Table 9-2: Selected POC Hematology Systems ..................................................................... 265
Figure 9-1: Hematology Market, 2011 and 2016................................................................... 266
Table 9-3: Revenue History of the Major Hematology Vendors 2009-2011, .................... 267
CHAPTER TEN: COAGULATION

Table 10-1: Selected Commercial Plavix and Warfarin Dosing Tests, 2011 ...................... 279
Table 10-2: Worldwide Coagulation Sales by Segment 2011-2016 ..................................... 281
Table 10-3: Selected Coagulation Innovations ...................................................................... 283
Table 10-4: World POC Coagulation Sales, 2011 ................................................................. 286
Table 10-5: Selected CLIA Waived PT Devices .................................................................... 286
Table 10-6: Top Coagulation Company Revenues 2009 2011........................................... 289
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY

Table 11-1: Selected Next Generation Sequencing Platforms ............................................. 298
Table 11-2: Selected Advanced Microbiology Platforms ..................................................... 302
Table 11-3: Worldwide Microbiology/Virology Sales by Type 2011-2016, ...................... 305
Table 11-4: Revenue of Selected MicrobiologyProduct Companies, 2011 ........................ 311
Table 11-5: Selected advanced techniques for positive blood cultures ............................... 317
Table 11-6: Lab-based infectious disease immunoassays, by test, 2011, ........................... 319
Table 11-7: Selected Infectious Disease Immunoassay Innovations .................................... 322
Table 11-8: Selected Professional-use POC Tests for Infectious Diseases .......................... 326
Table 11-9: Selected New Instruments for Molecular Infectious Disease Testing ............. 328
Table 11-10: Molecular Test Sales, Infectious Diseases, 2011-2016, ................................. 329
Table 11-11: Selected Molecular Tests for Fungal Infections .............................................. 332
Table 11-12: Selected Molecular POC devices ...................................................................... 333
Table 11-13: Selected Infectious Disease Molecular Test Innovations................................ 334
Table of Contents
xxv
CHAPTER TWELVE: BLOOD BANKING SERVICES

Table 12-1: Laboratory Screening Of Blood Donations For Transfusion
-Transmissible Infections, Number Of Countries .............................................................. 338
Table 12-2: Blood Component Usage ..................................................................................... 339
Table 12-3: Worldwide Blood Bank Sales, 2011-2016 .......................................................... 348
($ millions)................................................................................................................................. 348
Table 12-4: Selected Blood Bank Innovations ....................................................................... 359
CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY

Table 13-1: Selected Lab Expansions..................................................................................... 364
Table 13-2: Selected Histology Test Services......................................................................... 366
Table 13-3: Worldwide Histology/Cytology Sales by Type 2011-2016, ($ million) ............ 368
Table 13-4: Selected Histology Automation .......................................................................... 370
Table 13-5: Selected Histology IT Solutions .......................................................................... 371
Table 13-6: Revenues of the Major Histology Companies $ million, 2009-2011 ................ 372
Table 13-7: Selected vendors of traditional histology stains ................................................ 373
Table 13-8: Selected HPV Test Innovations .......................................................................... 378
Table 13-9: Major Pharmacodiagnostic Markers ................................................................ 381
Table 13-10: Selected Pharmacodiagnostic Histology Tests ................................................ 384
Table 13-11: Selected Digital Imaging Innovations .............................................................. 388
Table 13-12: Selected tissue microarray products ................................................................ 390
Table 13-13: Selected innovations in CTC technology ......................................................... 393
Table 13-14: Selected companies involved in chromosomal analysis of cancer cells ......... 395
Table 13-15: Selected Innovations in Flow Cytometry ......................................................... 398
Table 13-16: Selected CD4 Test Innovations, 2008-2009 ..................................................... 399

Three: World Markets

69
On top of this, the FDA and CMS (U.S. government agencies) are looking to
reorganize reimbursement and the regulation of IVDs and especially lab developed tests
and molecular assays the tests that provide the most opportunity for market growth.
There is little doubt that IVD marketing in the U.S. in for a bit of a bumpy ride, but
there is evidence that the importance of IVD innovation is well recognized. A report
from the Lewin Group finds that screening and diagnostic laboratory tests are central to
achieving some of the most important goals of healthcare reform. According to the
report, tests for conditions such as diabetes, cervical cancer, drug-resistant infections, and
metastatic colon cancer are enabling important strides in early detection and diagnosis, as
well as in helping physicians select treatments that will work most effectively for
patients. The net result is often better health outcomes for patients, as well as greater
savings and economic efficiencies for the healthcare system, all key goals of healthcare
reform. The report addresses the cost and clinical implications of lab testing by focusing
on four areas: Rapid diagnostic tests for hospital-acquired MRSA infections, KRAS
genetic testing, HbA1c blood glucose testing, and HPV DNA testing for cervical cancer.
The report was sponsored by the American Clinical Laboratory Association, Results for
Life, and AdvaMed. The full report is available at www.labresultsforlife.org and
www.advamed.org.
A discussion of the events of the past few years could occupy a report all alone, but
this review will provide the highlights of changes in progress.
RUO/IUO Issues
Many tests are launched as RUO (research use only) and IUO (investigation use
only). This gives manufacturers a chance to gather information for eventual market
clearance. May 2011, the FDA issued a Draft Guidance for Industry and FDA Staff Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only
or Investigational Use Only. The Agency recognized the need for this guidance due to
the marketing of unapproved and uncleared IVD products for purposes other than
research or investigation (for example, for clinical diagnostic use).
This, according to the Agency, has led in some cases to diagnostic use of laboratory
tests with unproven performance characteristics and manufacturing controls that are
inadequate to ensure consistent manufacturing of the finished product. Use of such tests
for clinical diagnostic purposes may mislead healthcare providers and cause serious
Four: Trends
113
Determination for using these tests for diagnosis or treatment of cancer. But a statement
from CMS (Centers for Medicare & Medicaid Services) recognized the increasing
evidence to support PGx tests for cancer: CMS is aware that the body of evidence on the
role of pharmacogenomic testing in cancer continues to evolve. Recognizing the rapid
accumulation of such evidence, CMS seeks guidance from the panel to inform future
coverage determinations. A meeting of MEDCAC (Medicare Evidence Development &
Coverage Advisory Committee) was called to explore the subject. It was held in January
2010 but no decisions have been reported.
Reimbursement depends largely on the value proposition. Especially when the
average cost of molecular testing is about $XXX for simple one-target tests and as high as
$XXX for test panels. Bringing new products to market under current healthcare
economics means that medical device companies will have to use the most advanced
marketing techniques and demonstrate credible value for their products if they are to win
in the marketplace. A major key to success is managing the value perception of a product
in relation to the competition and the status quo in test procedures. Market value
perception and competition can make or break the reimbursement proposition.
Quite frankly, keeping up with developments in the new menu of molecular
diagnostics and specialized immunoassays is not that easy. Due to the increasing number
of genetic tests coming on the market, there is confusion among physicians, patients, and
payers about which tests are clinically appropriate. There are more than 2,000 diseases
for which molecular diagnostic and genetic tests are available. Further, companies have
released protein markers for many of these diseases, The debate between the value of
each of these test modalities adds more dimension to the situation.
Help is on the way, a number of initiatives have been launched to help payers sort
through the maze of specialized tests. Medcos DNA Direct's Policy & Benefit Support
Program provides information to help payers manage molecular diagnostic and genetic
tests. It provides access to an online portal that contains detailed clinical information for
individual tests as well as coverage decision support. DNA Directs accredited utilization
management programs to help payers ensure the appropriate use of the more than 2,000
genetic and molecular tests available today. DNA Direct's national call center of genetic
experts, complemented by online decision support services help physicians and patients
determine if genetic tests are appropriate and how to use genetic test results to guide
clinical decisions.
Eight: Molecular Systems

245
There is also increasing evidence that early, aggressive treatment of RA can lead to
improved outcomes and therefore it is crucial that markers of therapeutic efficacy are
used to track a patient's status over time.
The development of RA does not happen overnight and includes multiple factors that
act to varying degrees in different patients. Therefore, PMx tests that can specifically
identify patients who most need the therapy and that also gives you an indication of how
well the drug is working, would be an ideal approach to RA management.
Initiatives are underway led by the American College of Rheumatology (ACR) and
the European League Against Rheumatism (EULAR) to establish quantitative objective
indicators of disease activity to assist in routine clinical practice and for outcomes
measures in clinical trials.
There is no cure for any of the types of arthritis. Treatment options vary depending on
the type of arthritis and aim to reduce inflammation in the joint, which decreases pain.
This begins with over the counter analgesics such as acetaminophen, ibuprofen and
naproxen.
A number of targeted are used in the most severe cases, including anti-TNF- agents
(infliximab, etanercept and adalimumab), treatments directed against IL1 (anakinra), a
CTLA4-directed T-cell modulator (abatacept) and a monoclonal antibody against CD20
that serves as a B-cell modulator (rituximab).
Targeted drugs in development include: anti-IL6 (tocilizumab) and anti-TNF-
(golimumab, certolizumab), as well as other agents targeting CD20 (ocrelizumab,
ofatumumab and TRU-015) Drugs targeted to other pathways within the RA
inflammatory cascade include the lymphotoxin pathways (baminercept), B-cell activation
pathways targeting BAFF, BLyS and APRIL (briobacept, belimumab and atacicept) and
several intracellular kinase pathways, including JAK-3 and Syk.
These emerging therapies offer great promise as well as challenges. They will likely
be expensive and not uniformly effective. The need to identify biomarkers of treatment
response and toxicity specific to the various agents will greatly enhance our ability to
tailor treatment to individual RA patients.
A number of gastrointestinal conditions including irritable bowel disease (IBD) and
Crohn disease are autoimmune diseases that cause inflammation of the digestive or
gastrointestinal tract. Crohn disease is the most common form of irritable bowel disease.
Nine: Hematology
263
LIS interfaces via its data center, and lab staff and physicians can work anywhere
because the system is entirely browser-based.
Table 9-1 presents a selection of hematology instrument and automation innovations
that were announced in 2010 and 2011.
Table 9-1
Selected Hematology Innovations, 2011
Company
Location
Details
Status
Source: Kalorama Information, company reports
DECENTRALIZED HEMATOLOGY TESTING

Used in innumerable diagnoses and treatments, including those for infection and
leukemia, CBC is one of the most ordered laboratory tests. In addition, a CBC test is
routinely ordered during an annual wellness check up.
In the U.S. alone, there were some XX xxxx CBC tests run in a physician office.
The market potential for decentralized hematology testing, worldwide, has lead to the
development of several tabletop hematology analyzers designed specifically for small
labs and decentralized test sites such as physician offices and clinics.

Eleven: Microbiology Companies

305
Table 11-3
Worldwide Microbiology/Virology Sales by Type
2011-2016, ($ million)
Sales
2011
%
Mkt
Sales
2016
% CAGR
Mkt
Infectious Diseases - Immunos

Infectious Diseases - Rapid
ID/AST
Infectious Diseases Molec/DNA
TOTAL
Supplies
Breakout of ID/AST
Sales
2011
%
Mkt
Sales
2016
% CAGR
Mkt
ID/AST
Panels and Reagents,
automated
Panels and Reagents, manual
Blood Culture
Chromogenic Media
Rapid Micro
Source: Kalorama Information
For the next five years micro vendors can expect to see XX-XX% annual growth in the
more mature traditional microbiology and immunoassay sectors with XX% annual growth
in nucleic acid assays.
For the next five years there will be increased demand for microbiology and virology
products due to emerging infectious diseases, nosocomial infections (hospital acquired),
and antibiotic resistance. However, vendors will be challenged to develop products that
can adapt to these market forces that because microorganisms are living entities, are
continuously changing.

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Worldwide Mkt for IVD Tests 8th Edition

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CHAPTER ONE: EXECUTIVE SUMMARY ............................................................................ 1

CHAPTER TWO: INTRODUCTION...................................................................................... 13

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS ............ 51

CHAPTER FOUR: TRENDS AND INNOVATION ................................................................ 101

Copyright 2012 Kalorama Information

CHAPTER FIVE: POINT-OF-CARE TESTS ...................................................................... 133

CHAPTER SIX: THE CORE LAB ...................................................................................... 155

CHAPTER SEVEN: IMMUNOASSAYS ................................................................................ 171

CHAPTER EIGHT: MOLECULAR ASSAYS ....................................................................... 213

CHAPTER NINE: HEMATOLOGY..................................................................................... 259

CHAPTER TEN: COAGULATION...................................................................................... 271

CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY.................................................. 293

CHAPTER TWELVE: BLOOD BANKING SERVICES ......................................................... 337

CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY .................................................... 361

CHAPTER FOURTEEN: COMPANY PROFILES, THE TOP TIER ....................................... 401

CHAPTER FIFTEEN: COMPANY PROFILES, THE SECOND TIER .................................... 535

CHAPTER SIXTEEN: COMPANY PROFILES, THE THIRD TIER ....................................... 681

CHAPTER SEVENTEEN: BLOOD BANK SPECIALISTS...................................................... 751

CHAPTER EIGHTEEN: COAGULATION SPECIALISTS ..................................................... 777

CHAPTER NINETEEN: DIABETES SPECIALISTS .............................................................. 787

CHAPTER TWENTY: HEMATOLOGY SPECIALISTS ......................................................... 831

CHAPTER TWENTY A: COMPANIES SPECIALIZING IN CIRCULATING

CHAPTER TWENTY-ONE: HISTOLOGY SPECIALISTS................................................... 857

CHAPTER TWENTY-TWO: IMMUNOASSAY SPECIALISTS .............................................. 911

CHAPTER TWENTY-THREE: MICROBIOLOGY SPECIALISTS ......................................... 979

CHAPTER TWENTY FOUR: MOLECULAR TEST SPECIALISTS ...................................... 1067

Copyright 2012 Kalorama Information

CHAPTER TWENTY-FIVE: POINT-OF-CARE SPECIALISTS .......................................... 1183

CHAPTER TWENTY-SIX: TEST SERVICE PROVIDERS .................................................. 1219

CHAPTER TWENTY-SEVEN: COMPANY PROFILES: INFORMATION TECHNOLOGY

CHAPTER TWENTY-EIGHT: CORE LAB AND OTHER COMPANIES ............................. 1403

Copyright 2012 Kalorama Information

CHAPTER ONE: EXECUTIVE SUMMARY

CHAPTER TWO: INTRODUCTION

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

CHAPTER FOUR: TRENDS AND INNOVATION

CHAPTER FIVE: POINT-OF-CARE TESTS

CHAPTER SIX: THE CORE LAB

CHAPTER SEVEN: IMMUNOASSAYS

Copyright 2012 Kalorama Information

CHAPTER EIGHT: MOLECULAR ASSAYS

CHAPTER NINE: HEMATOLOGY

CHAPTER TEN: COAGULATION

CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY

CHAPTER TWELVE: BLOOD BANKING SERVICES

CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY

Copyright 2012 Kalorama Information

Three: World Markets

Eight: Molecular Systems

Source: Kalorama Information, company reports

DECENTRALIZED HEMATOLOGY TESTING

Copyright 2012 Kalorama Information

Eleven: Microbiology Companies

Infectious Diseases - Immunos

Source: Kalorama Information

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