Test Overview
Test Methodology

Fluorescence In Situ Hybridization (FISH)

Test Usage

This test detects rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. This test is FDA-approved to aid in identifying those patients eligible for treatment with crizotinib, a small molecule inhibitor of the ALK tyrosine kinase. FISH is performed using a dual color break apart probe (Abbott Molecular) to qualitatively assess for the presence of ALK gene rearrangements. This test is intended only for NSCLC tissue specimens that have been fixed in 10% neutral buffered formalin and embedded in paraffin.

Reference Range *

Interpretive report provided. This test detects the Apo E2, E3, and E4 genes.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

This assay may fail to detect ALK rearrangements in some cases due to intrachromosomal proximity of some fusion partners. This test will detect ALK rearrangements but will not identify the fusion partner.

Test Details
Days Set Up
Monday - Thursday
Analytic Time

3 - 10 days

Soft Order Code
MiChart Code
ALK Rearrangement for NSCLC, FISH
  • MALK
  • ALK (2p23) by FISH for NSCLC
  • Crizotinib evaluation for Non-small cell lung cancer (NSCLC)
Molecular Diagnostics
Molecular Diagnostics
Specimen Requirements
Collection Instructions

A formalin-fixed, paraffin-embedded tissue block containing sufficient neoplastic cells is preferred. Unstained slides (3, 4-micron slides) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature.

Normal Volume
Formalin-fixed, paraffin-embedded tissue
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

CPT Code
Fee Code
Pro Fee CPT
NY State Approved