Cell Phone-Enabled Diagnostics

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AUGUST 2012

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

Introduction ......................................................................................................................... 1
Scope and Methodology ...................................................................................................... 2
Market Trends ................................................................................................................... 4

CHAPTER TWO: INTRODUCTION .......................................................................7

Background .......................................................................................................................... 7
The Case For Cell phone-Enabled Devices ....................................................................... 9
Consulting From Far and Wide ....................................................................................... 12
Point of View ...................................................................................................................... 13

CHAPTER THREE: ENABLING TECHNOLOGIES AND

COMMERCIALIZATION ARRANGEMENTS....................................................15
Overview............................................................................................................................. 15
Definition of Cell Phone-Enabled Diagnostics ............................................................... 16
Advances in Microfluidics and Biosensors ...................................................................... 17
The Interface and Communication Technologies ........................................................... 19
UC Davis Interface .......................................................................................................... 20
Frontline SMS Medic ...................................................................................................... 20
iPhones, Blackberrys and PDAs...................................................................................... 21
Are Consumers Ready for mHealth?............................................................................... 21
Physician and Payor Opinion........................................................................................... 22

CHAPTER FOUR: MARKET ANALYSIS - CELL PHONE-ENABLED

DEVICES ....................................................................................................................31
Overview............................................................................................................................. 31
Cell phone-Enabled Diagnostics For Diabetes ................................................................ 33
Scourge of Diabetes ........................................................................................................ 33
Market Status of New Cell phone Glucose Monitors...................................................... 35
Regulation ....................................................................................................................... 36
Diagnostics in Cars? ........................................................................................................ 39
Cell phone-Enabled Rapid Immunoassays...................................................................... 39
Decentralized Trend ........................................................................................................ 41
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Table of Contents
ii
Lateral Flow Tests ...........................................................................................................41
Focus on Infectious Diseases ..........................................................................................44
Cell-Phone Enabled Microscopy ......................................................................................50
Histology .........................................................................................................................53
Microbiology ...................................................................................................................55
Hematology .....................................................................................................................58
Cell Phone-Enabled Molecular Tests ...............................................................................61
Amplification ..................................................................................................................62
Nucleic Acid Lateral Flow ..............................................................................................63
Microfluidic Cartridge-Based Approaches......................................................................64
The Commercial Outlook for Cell phone-enabled Diagnostic Devices .........................69

CHAPTER FIVE: CONCLUSION ......................................................................... 71

CHAPTER SIX: COMPANIES AND OFFERINGS ............................................. 75
Accuster Technologies Pvt. Ltd. .......................................................................................75
AgaMatrix, Inc. ..................................................................................................................76
Alere ....................................................................................................................................77
ARKRAY............................................................................................................................78
ARUP Laboratories ...........................................................................................................79
Axxin ...................................................................................................................................80
BBInternational .................................................................................................................80
BIO-key International, Inc. ..............................................................................................81
BodyTel Europe GmbH ....................................................................................................82
California Institute of Technology (Caltech) ..................................................................83
CellScope ............................................................................................................................84
CellScope Inc. .....................................................................................................................85
Clearbridge BioLoc Pte Ltd..............................................................................................86
Columbia University..........................................................................................................87
DNAFORM ........................................................................................................................88
eSTI (Electronic self-testing instruments) ....................................................................89
Entra Health Systems ........................................................................................................89
Freescale Semiconductor ..................................................................................................91
Bill and Melinda Gates Foundation .................................................................................92

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in whole or in any part, is strictly prohibited.

Table of Contents
iii
Gene-Z ................................................................................................................................ 92
Genomic Health, Inc. ......................................................................................................... 93
GenPrime, Inc. ................................................................................................................... 95
Gentag Inc. ......................................................................................................................... 96
GlySens Incorporated ....................................................................................................... 98
Harvard University Medical School ................................................................................ 98
Heidelberger-Medical-Marketing GmbH (HMM GmbH) ............................................ 99
HolGenTech Inc. ................................................................................................................ 99
Holomic LLC (formerly Microskia) .............................................................................. 100
Infopia Co Ltd ................................................................................................................. 102
Intelligent Optical Systems, Inc...................................................................................... 104
Korea Advanced Institute of Science of Technology (KAIST) .................................... 105
Labonfoil Consortium ..................................................................................................... 106
Leica Microsystems ......................................................................................................... 107
Lifescan Inc. ..................................................................................................................... 108
Massachusetts General Hospital .................................................................................... 109
MAVAND Solutions GmbH ........................................................................................... 110
MEDIWISS Analytic GmbH .......................................................................................... 111
Medtronic Inc. ................................................................................................................. 112
MycroLab Pty Ltd. .......................................................................................................... 113
NextLab ............................................................................................................................ 114
Oasis Diagnostics ............................................................................................................. 115
Oasis Scientific, Inc. ........................................................................................................ 115
QIAGEN N.V. .................................................................................................................. 116
QuantuMDx Group Limited .......................................................................................... 117
Sano Intelligence .............................................................................................................. 120
Skannex ............................................................................................................................ 121
TelCare Inc. ..................................................................................................................... 122
Universit Commerciale Luigi Bocconi ......................................................................... 123
University of Arizona ...................................................................................................... 124
University of Washington ............................................................................................... 124
X out TB ........................................................................................................................... 125
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Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Table of Contents
iv
L

CHAPTER THREE: ENABLING TECHNOLOGIES AND

COMMERCIALIZATION ARRANGEMENTS 
Table 3-1: Selected Cell phone Enabled Test Devices ....................................................19

CHAPTER FOUR: MARKET ANALYSIS - CELL PHONE-ENABLED

DEVICES ................................................................................................................... 31
Table 4-1: Selected Cell phone-based Glucose Meters ...................................................34
Table 4-2: Selected Wireless Enabled Glucose Monitors, 2011 .....................................37
Table 4-3: Rapid Immunoassay Test Sales by Test Category
2011-2016, $ million ...........................................................................................................40
Table 4-4: Selected Cell phone-enabled Rapid Immunoassay Innovations..................44
Table 4-5: Selected Molecular Tests and Platforms for Infectious Diseases ................65
Table 4-6: Selected cell phone-enabled molecular test devices in development ...........68

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Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Two: Introduction
10

In developing countries, consumers use their cell phone for banking and as a
replacement for bank debit cards. Cell phone messages also advise patients to keep to
their treatment schedules and provide health and nutrition education. Expecting and new
mothers can receive free weekly text messages via text4baby. These messages coincide
with the baby's due date or date of birth. Started in February 2010, and led by National
Healthy Mothers Healthy Babies Coalition, text4baby has sent more than XXXX health
tips to people in underserved areas.
On the professional level, smartphone application services provide treatment
guides and information on new developments that are delivered directly to a cell phone.
Cell phones are also commonly used to capture and send digital hematology and
histology slide images images for consultation. Now a number of apps have emerged in
test segments not traditionally associated with wireless connectivity such as guides to
using molecular lab technologies, such as Qiagens iPhone and iPad application for
moolecular testing with tables of commonly used lab buffers and solutions, as well as a
variety of conversion and dilution calculators. The app allows users to watch more than
20 video tutorials on technologies in application areas such as automation, gene
expression analysis, genotyping, and pyrosequencing.
For medical professionals, anatomical pathology wireless communications help
provide needed specialty consultations to rural and underserved areas. Pathologists can
now provide a diagnosis without accessing a computer, microscope, or the original
specimen. And they can do so from the comfort of their own home or any other location
that has cell phone reception. All they need is an Apple iPhone or other wireless
communication device.
For example, the Institute for Medical Informatics (Oslo, Norway) introduced
Interpath for iPhone, an application for reviewing and navigating high-quality images of
pathology slides over the multimedia cell phone. Interpath uses a microscope slide
scanner and Web server.
Health Discovery Corporation is developing a melanoma/skin cancer mobile
phone application, which will enable people to take a picture of a mole, lesion or
birthmark on their bodies using their mobile phones, send the image to Health Discovery,
and immediately receive (on their mobile phone) a risk assessment for melanoma and
other skin cancers.

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in whole or in any part, is strictly prohibited.

Four: Market Analysis

48

national syphilis policy recommends screening for individuals who have multiple sex
partners, unprotected sex or partners with a history of sexually transmitted infection
(STI).
Similar guidelines have been established in Canada, Russia, the UK, eastern
Europe and central Asia. Despite these recommendations, a large number of high-risk
patients in many regions of the world fail to receive regular syphilis screening.
For many years, the World Health Organization (WHO) and other international
health agencies had called for better tools for patient diagnosis, surveillance/monitoring,
and blood safety that can be used by community health workers in low-infrastructure
settings. In the mid 1980s, USAID anticipated that advances in biotechnology could lead
to suitable diagnostic solutions and funded PATH to support research and development.
That program, called Diagnostics for Community Health (DiaTech), set the stage
for groups such as the STD Diagnostics Initiative and Tuberculosis Diagnostics Initiative.
They oversee the development of improved tools for diagnosis and surveillance of
diseases.
Currently the Bill & Melinda Gates Foundation and the Wellcome Foundation
have sponsored meetings for discussion of strategies to prioritize, obtain, and accelerate
the development of necessary diagnostics.
Many sexually transmitted infections are asymptomatic, especially in women,
they are often undiagnosed and serve as a resevoir for further infections. Undetected
infections often lead to serious consequences including: an increased risk of HIV
transmission, adverse outcomes in pregnancy ectopic pregnancy, stillbirths,
prematurity, and children may be born with blindness, pneumonia, congenital syphilis,
and herpes encephalitis. The chronic complications in infected sexually active men and
women include: chronic pain, lifelong infection, infertility, and genital cancers including
cervical cancer.
The tragedy of the mismanagement of STD diagnosis is that these diseases are
totally curable and easily treated with relatively inexpensive therapeutics. Further,
prevention and early detection of STDs will help prevent the spread of HIV. The U.S.
CDC has reported that those infected with STDs are at least two to five times more likely
than uninfected individuals to acquire HIV infection if they are exposed to the virus.

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in whole or in any part, is strictly prohibited.

Four: Market Analysis

67

The scientists reported that the idea was derived from the fact that touch screens
work by recognizing the electronic signs from the touch of the finger, and so the presence
of specific proteins and DNA should be recognizable as well. The touch screens on
smartphones, PDAs or other electronic devices work by sensing the electronic charges
from the user's body on the screen. Biochemicals such as proteins and DNA molecules
also carry specific electronic charges. Table 4-6 presents a selection of cell phoneenabled molecular test devices in development.
According to KAIST, the team's experiments showed that touch screens can
recognize the existence and the concentration of DNA molecules placed on them, a first
step toward one day being able to use the screens to carry out medical tests.
Since nobody would put blood or urine on a touch screen, the sample would be
placed on a strip, which would then be fed into the phone or a module attached to the
phone through an entrance point.
LabOnFoil is the acronym chosen to designate the project named Laboratory
Skin Patches and SmartCards based on foils and compatible with a smartphone. The
objective of the LabOnFoil project is to develop ultra-low-cost laboratories on chips. The
user will obtain the test results using a smartphone and a set of labcards and/or skin
patches, where the sample preparation and detection take place. Validation applications
include: a labcard for colorectal cancer monitoring using blood and a skin patch for
cocaine consumption testing of professional drivers.
The consortium is also developing the SmartBioPhoneT project in collaboration
with Spains IKERLAN Technology research centre. The SmartBioPhoneT is a portable
analytical instrument that will detect RNA, DNA and molecular markers. The results
will be captured by a special accessory into the phone, which then sends this information
to the central, all within an interval of 15 minutes.
Researchers at University of Michigans Institute of International Health in
collaboration with colleagues at the Universitys department of Civil and Environmental
Engineering are developing the Gene-Z device for point-of-care genetic testing using a
smartphone interface. The prototype consists of a disposable plastic chip with four arrays
containing the dried primers required for a genetic assay, allowing parallel processing of
four samples with multiple genetic markers. Using a disposable valve-less polymer
microfluidic chip containing four arrays of 15 reaction wells each with dehydrated

Copyright 2012 Kalorama Information

Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.