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
Not provided.
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.
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
No genes
Gene
LOINC Codes
- 78205-2 - ALK rearrange Bld/T Ql FISH
- 50397-9 - Mol dx interp Bld/T Ql
- 78210-2 - ALK rearrange Bld/T FISH-Imp
- 62356-1 - Chrom analy result (ISCN)
- 42349-1
- 31208-2 - Specimen source
- 80398-1 - Unique ID Current sample
- 85069-3 - Lab test method
- 48767-8 - Annotation comment Imp
- 18771-6 - Provider signing name
- 62364-5 - Test performance info Spec
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.
