NSCLC ALK Break Apart by FISH

ALK rearrangement is detected in 5%-16% of non-small cell lung cancer (NSCLC) in the form of inv(2)(p21 p23), as determined by FISH and serves as a biomarker for therapy response. ALK FISH testing can be performed simultaneously as EGFR mutation testing or after EGFR mutation testing is completed with a negative EGFR mutation result. NSCLC with ALK rearrangement is highly sensitive to ALK-kinase inhibition. The FDA has approved Xalkori (crizotinib) for locally advanced or metastatic NSCLCs that are ALK rearrangement positive.

Overview

Clinical Indications Clinical Utility

Non-Small Cell Lung Cancer. Identifies patients that may benefit from targeted therapeutics such as EGFR TKIs. FDA-approved FISH test is necessary for treatment with Xalkori (crizotinib).

Methodology and Interpretation

Fluorescence in situ hybridization (FISH). In cells where the ALK gene is intact, fusion signals (red/green or yellow) are observed. Upon chromosomic rearrangement involving the ALK gene, the most commonly observed pattern is one fusion signal (red/green or yellow), which represents the normal chromosome 2, and one red and one green signal, which represents the derivative chromosomes.

Assay Specifications

Reporting Results are reported as Positive: >50% of 100 sample cells show ALK rearrangement Negative: <10% of 100 sample cells show ALK rearrangement Equivocal: 10-50% of sample cells show ALK rearrangement For equivocal samples, an additional 50 cells are scored and reported as: Positive: 15% of cells show ALK rearrangement Negative: <15% of cells show ALK rearrangement

Specimen Requirements 10% neutral buffered formalin-fixed paraffin-embedded (FFPE) tissue. 3-5m thick FFPE sections on positively coated slides. Stored and transported at room temperature. Licensure CAP (Laboratory #: 7191582, AU-ID: 1434060), CLIA (Certificate #: 31D1038733), New Jersey (CLIS ID #: 0002299), New York State (PFI: 8192), Pennsylvania (031978), Florida (800018142), Maryland (1395) CPT Codes 88368x2

TAT 5-7 days

Xalkori is a registered trademark of Pfizer.

201 Route 17 North Rutherford NJ 07070 Office 201.528.9200 Fax 201.528.9201 www.cancergenetics.com
2013 Cancer Genetics, Inc. All rights reserved.

Patient Name: Sex: q Male q Female Date of Birth: Specimen: Collected: Received: Reported: Clinical Hx:

Accession Number: CGI ID No: Ordering Physician: Client: Client Account No: Client ID No: Client Address: Telephone:

ALK BREAK APART FISH REPORT ON FFPE SAMPLE

PROBE SETS CHROMOSOME LOCI 2p23 (ALK) # CELLS ANALYZED | ABNORMAL 100 % OF ABNORMAL CELLS 100% % OF NORMAL CELLS Nil RESULTS Positive for ALK Rearrangement

% of abnormal cells >50% = Positive for ALK Rearrangement % of abnormal cells <10% = Negative for ALK Rearrangement % of abnormal cells 10-50% = Equivocal In case of equivocal samples between 10-50% positive cells, a 3rd reader scores 50 cells and percentage is recalculated. % of positive cells 15% = Positive for ALK rearrangement. % of positive cells < 15% = Negative for ALK rearrangement. ISCN NOMENCULATURE: nuc ish(5ALK,3ALK)x3(5ALK con 3ALKx2)[100] Summary: Final Interpretation: Positive For ALK Rearrangement

The fluorescence in situ hybridization (FISH) analysis done on lung carcinoma specimen (FFPE) showed ABNORMAL signal pattern with the rearrangement of ALK gene observed in 100% cells.

Probe Map: Ideogram: Probe Ideogram

Map

ALK BA(2p23)
End of Report

201 Route 17 North Rutherford NJ 07070 Office 201.528.9200 Fax 201.528.9201 www.cancergenetics.com

041013 2013 Cancer Genetics, Inc. All rights reserved.