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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. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

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)