Melanoma, BRAF V600 Mutation, Cobas®
Also known as: B-RAF, cobas® 4800 BRAF V600 Mutation Test
Use
This FDA‑cleared real‑time PCR assay on the cobas 4800 platform assesses for mutations at codon 600 of the BRAF gene, particularly V600E, which are present in approximately 40‑60% of melanomas. Melanomas with codon 600 BRAF mutations are associated with response to the BRAF‑directed kinase inhibitor vemurafenib (ZELBORAF®). Tumor DNA is extracted from fixed tumor tissue and subjected to real‑time PCR, with approximate sensitivity of 5% mutant‑bearing cells in a mixed sample. Other codon 600 BRAF mutations, besides the most common V600E (c.1799T>A), may not be reliably detected by this method.
Special Instructions
Not provided.
Limitations
Approximate sensitivity of 5% mutation‑bearing cells; other BRAF V600 codon mutations besides V600E may not be detected reliably by this method.
Methodology
PCR-based (PCR)
Biomarkers
No genes
Gene
Result Turnaround Time
3 days
Related Documents
For more information, please review the documents below
Specimen
Tissue
Volume
Not provided
Minimum Volume
Not provided
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |
Other tests from different labs that may be relevant