Lung Cancer, ALK (2p23) Rearrangement, FISH, Tissue
Use
The test is useful for identifying patients with non-small cell lung carcinoma who may benefit from treatment with directed tyrosine kinase inhibitors. Rearrangements of the anaplastic lymphoma kinase (ALK) gene are found in approximately 3% to 5% of non-small cell lung carcinomas. Clinical studies have shown that lung cancers harboring ALK rearrangements are resistant to epidermal growth factor receptor tyrosine kinase inhibitors, but may be highly sensitive to directed tyrosine kinase inhibitors like crizotinib or alectinib, making this test potentially significant for therapeutic decision-making.
Special Instructions
This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization probes). No analysis charges will be incurred if an insufficient number of representative cells are available for analysis. A pathology report is required for testing. Core ordering is supported by ancillary probes at consultant discretion, which are performed with additional charge.
Limitations
This test does not include a pathology consultation. While results may indicate a likely response to ALK inhibitor therapy, selection of treatment remains a clinical decision. The assay does not rule out other chromosome abnormalities. Non-formalin fixed specimens or decalcified tissues might not be successful for FISH analysis, and additional testing may be required for atypical or unbalanced fluorescence in situ hybridization results.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 78205-2
- 50397-9
- 78210-2
- 62356-1
- 42349-1
- 31208-2
- 80398-1
- 85069-3
- 48767-8
- 18771-6
- 62364-5
Result Turnaround Time
7-9 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods will be attempted but are less favorable for successful results by FISH testing; provide fixation method used.
Causes for Rejection
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.