Solid Tumors

The FDA-approved Vysis® ALK Break Apart FISH Probe Kit detects 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.

disease state indication(s)
Non-Small Cell Lung Cancer (NSCLC)

clinical use
ALK gene rearrangements are found in 2-5% of NSCLC cases. The in-frame fusion of an upstream partner gene and the downstream ALK kinase domain results in production of a chimeric protein with increased kinase activity. The presence of a rearrangement involving the ALK gene in non-small cell lung cancer (NSCLC) determines eligibility for targeted therapies (such as crizotinib, ceritinib, alectinib, and brigatinib).

methodology/product platform
Fluorescence in situ hybridization (FISH)

specimen type and requirements
Preferred: One (1) or two (2) formalin-fixed, paraffin-embedded (FFPE) blocks containing tumor tissue from the most recent surgery or biopsy.
Acceptable Alternative: Two (2) to three (3) unstained FFPE tissue sections recently cut at 4 µm thickness on glass slides, plus accompanying H&E stained slide.
Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.

turnaround time
Tech-only (TC): 3 days
Global (TC & PC): 7 days

cpt code(s)
88377 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC) or Tech-only (TC)