Days Set Up
Monday - Thursday
Analytic Time

3 - 10 days

MiChart Code
ALK Rearrangement for NSCLC, FISH
Soft Order Code
MALK

Test Updated:

Synonyms

MALK
MLABEL
ALKBAP
ALK (2p23) by FISH for NSCLC
Crizotinib evaluation for Non-small cell lung cancer (NSCLC)

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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.

Specimen Requirements

Offsite 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
Minimum Volume
 

Billing Information

CPT Code
88377-TC
Pro Fee Code
 
Insurance Auth Info
 
LOINC
 

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.