A Rapid, Comprehensive ALK FISH Test for NSCLC Therapy Selection

NeoGenomics offers FDA-approved FISH testing for ALK gene rearrangements in NSCLC. This test:

Identifies patients eligible for treatment with XALKORI® (crizotinib)
Approximately 3-5% of non-small cell lung carcinomas (NSCLC) have a rearrangement of the ALK gene. Patients with such tumors have been shown to respond to the ALK kinase inhibitor XALKORI® (crizotinib).
Fulfills NCCN Guidelines
ALK rearrangement testing by FISH and EGFR molecular testing are recommended for recurrent or metastatic cases with histological subtypes of adenocarcinoma, large cell carcinoma, or NSCLC NOS (not otherwise specified).
Is more comprehensive than other test methods
Molecular testing methods such as PCR currently detect ALK rearrangements with only one of several possible genes (EML4-ALK), and may not detect all variants of even that rearrangement. FISH targets all potential ALK fusion rearrangements. Commercially-available antibodies for IHC do not have satisfactory sensitivity and specificity for ALK detection in lung tissues.

Test Detail:

Intended Use

The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).

Testing Options

Global (complete) or tech-only

Specimen Requirements

Paraffin block with 10% neutral buffered formalin-fixed paraffin-embedded (FFPE) lung tissue plus one H&E slide cut at 4-5 microns. If tech-only, please circle the invasive area.
If ordering additional tests such as EGFR and/or KRAS, please note preferred testing sequence if limited tumor is present.