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FISH, ALK 2p23 Rearrangement, Lung Cancer (NSCLC)
Test Code91028
CPT Codes
88271 (x2), 88274
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue collected in an IHC specimen transport kit
Minimum Volume
3 slides
Other Acceptable Specimens
5 unstained, charged (+) slides collected in an IHC specimen transport kit
Instructions
Lung tissue biopsy, formalin-fixed paraffin-embedded block or charged/+slides from formalin-fixed paraffin embedded tissue. Specimen must be fixed in 10% neutral buffered formalin. Fixation between 6 and 48 hours is recommended.
Pathology report must accompany paraffin block or slides. Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis. Do not freeze.
Pathology report must accompany paraffin block or slides. Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis. Do not freeze.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: See instructions
Refrigerated: Indefinite
Frozen: See instructions
Methodology
Fluorescence in situ Hybridization (FISH)
FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M. Sets up 7 days a week.
Clinical Significance
Non-small cell lung cancer is the leading cause of cancer death worldwide. Tyrosine kinase inhibitors have been demonstrated to reduce lung cancer cell proliferation. The therapeutic efficacy of inhibiting ALK in tumors that were selected by ALK positivity using FISH has been demonstrated in an early-phase clinical trial of a small molecular inhibitor of the ALK tyrosine kinase. The Vysis ALK Break Apart FISH probe kit is a qualitative test to detect rearrangements involving the ALK gene in formalin-fixed paraffin embedded non-small cell lung cancer tissue specimens to aid in identifying those patients eligible for treatment with XALKOR (crizotinib).
