Pseudonyms: ALK (2p23), EML4-ALK Fusion, Lung Cancer, Non-small cell lung cancer, NSCLC, FISH
TURNAROUND TIME: 7 to 10 days
Fluorescence in situ hybridization (FISH) Analysis
Paraffin-embedded, formalin-fixed tissueblock or three 4 µm sections on positively-charged glass slides including one consecutive hematoxylin and eosin-stained (H and E) section with the tumor areas marked.
Body cavity fluids, fine needle aspirates and core cytology preps prepared by CellientTM cell block system
- Stability: Paraffin block: ambient temperature, indefinite
- Unacceptable Conditions: Tissue not verified for the presence of tumor by a pathologist; specimens fixed in fixatives other than formalin or alcohol (CellientTM cell block system)
Test Summary: Fluorescence in situ hybridization (FISH) analysisdesigned to determine the presence of a rearrangement of the ALK gene in non-small cell lung cancer cells (NSCLC). ALKgene rearrangements resulting from fusion of the EML4 gene with the ALK gene have been identified in a distinct subset of patients with NSCLC who do not have EGFR and KRAS mutations.EML4-ALK rearrangements are more common in adenocarcinomas of younger patients who are light smokers or who have never smoked.
Method: A dual-color FISH analysis performed on interphase nuclei using a break-apart ALK gene probe (Abbott Molecular); analysis of 200 interphase nuclei from tumor cells
Reference Values: An interpretive report will be provided.
Interpretation: A positive result (ALK rearrangement) is reported when the percent of cells with an abnormality exceeds the normal cutoff for the ALK probe. A positive result indicates a patient would benefit from an oral first- in-class ALK inhibitor, such as Pfizer’s approved NSCLC therapy, XALKORI® (crizotinib).
A negative result indicates no rearrangement of the ALK gene.
Indications for Use:
- Patients with non-small cell lung cancer who are being considered for targeted therapeutics