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Melanoma, BRAF V600 Mutation, Cobas®
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Test Code
BRAF
CPT Codes
81210
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Refrigerated: Indefinitely
Frozen: Unacceptable
Methodology
Real-Time Polymerase Chain Reaction (Cobas®)
Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 3 days
Reference Range
Not detected
Clinical Significance
This FDA-cleared real-time PCR assay on the cobas 4800 platform assesses for mutations at codon 600 of BRAF, particularly V600E, which are present in 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% mutation-bearing cells in a mixed sample. Other codon 600 BRAF mutations, beside the most common V600E (c.1799T>A) may not be detected by this method.
Tumor DNA is extracted from fixed tumor tissue and subjected to real-time PCR, with approximate sensitivity of 5% mutation-bearing cells in a mixed sample. Other codon 600 BRAF mutations, beside the most common V600E (c.1799T>A) may not be detected by this method.
Performing Laboratory
| Quest Diagnostics Nichols Institute-San Juan Capistrano, CA |
| 33608 Ortega Highway |
| San Juan Capistrano, CA 92675-2042 |
Last Updated: November 30, 2021
