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BRAF V600 (in melanoma) (FDA-approved) pin


Methodology: PCR

Clinical Significance:
The FDA-approved cobas 4800 BRAF V600 mutation test (IVD) is a real-time PCR assay designed to detect the presence of activating BRAF V600 mutations in melanoma and is the companion diagnostic test for the vemurafenib, a BRAF inhibitor. This assay will detect the V600E BRAF mutation (T1799A) as well as a subset of other less common activating BRAF V600 mutations (including some V600K BRAF mutations). BRAF mutations have been identified in 40% - 60% of malignant melanomas as well as other human cancers including colorectal cancer, ovarian cancer, and thyroid cancer. BRAF is part of a highly regulated signaling pathway that mediates the effects of growth factor receptors (such as EGFR) through RAS, RAF, MEK and ERK. Oncogenic mutations in BRAF result in a gain of kinase function, rendering the RAF-MEK-ERK pathway constitutively active in the absence of typical growth factors.

Organ: Skin & Mucosa

Disease State: Melanoma

CPT Code(s): 81210; 88381 may apply (reference only; CPTs may vary)

Turnaround Time: Within 4-8 business days of receipt

Schedule: Wednesday

Specimen Requirements:
Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)