MET Gene Amplification by FISH
Also known as: MET_FISH
Use
This test aids in prognostication and therapeutic decisions for neoplasms where MET gene amplification has been demonstrated. It is a screening test used to identify MET gene amplification, which may be relevant in various tumor types, including non-small cell lung carcinoma. High-level MET amplification is considered an emerging biomarker for therapy with crizotinib, as defined by the National Comprehensive Cancer Network guidelines.
Special Instructions
Include surgical pathology report with the specimen. If multiple specimens are sent, a pathologist fee may be applied for block selection, unless specified otherwise. Clarification is required if multiple specimens are not accompanied with specific instructions for testing.
Limitations
This assay is not approved as a predictive biomarker for the therapeutic agent Emrelis; a different test, the Ventana SP44 immunostain, is required. The MET gene amplification is defined by a MET/CEP7 ratio of 2.0 or greater or an average MET gene copy number per cell of 6.0 or greater. It has not been cleared or approved by the US Food and Drug Administration. The test is performed in a CLIA-certified laboratory.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
4 slides
Container
Paraffin block or slides on positively charged glass slides
Storage Instructions
Protect paraffin block and/or slides from excessive heat. Transport at room temperature; refrigerated conditions are also acceptable.
Causes for Rejection
Paraffin block with no tumor tissue remaining, fixation in any fixative other than 10 percent neutral buffered formalin, decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |