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BRAF Gene Mutation Assay, Melanoma

Test Number: 480450 CPT: 81210; 88381
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Special Instructions

Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363.


Formalin-fixed, paraffin-embedded (FFPE) tissue. Submit four precut, unstained slides from paraffin block in 5-μM sections and an H&E reference slide or formalin-fixed, paraffin-embedded tissue block containing ≥15% tumor.


Four unstained slides and one H&E slide stained or formalin-fixed, paraffin-embedded tissue block

Minimum Volume

2 mm x 2 mm tumor area


Slides, blocks

Storage Instructions

Maintain blocks/slides at room temperature.

Causes for Rejection

Tumor block containing insufficient tumor tissue or tumor fixed in a heavy metal fixative; broken or stained slides


Approximately 50% of melanomas have an activating mutation in the BRAF oncogene. The majority of these genetic alterations are the V600E (1799 T>A) mutation. Recent studies have shown that the drug vemurafenib (Zelboraf®) has clinical efficacy in tumors with the mutation. The Cobas® 4800 BRAFV600 Mutation test is approved by the US Food and Drug Administration (FDA) for the qualitative detection of the BRAFV600E mutation in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue.


The provided tumor tissue should be composed of ≥15% tumor cells for accurate test interpretation. Preparation of DNA from tissue samples is dependent on the quality of the provided specimen. Inadequate DNA extraction may occur in a significant number of paraffin-embedded samples.

The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 5% of mutant in a background of wild-type genomic DNA.


Real-time PCR and TaqMan® probe detection


Bloom KJ, Anderson SM, Schilling RC, et al. Molecular testing for BRAFV600 mutation in the BRIM-2 trial of the BRAF inhibitor vemurafenib (RG7204/PLX4032) in metastatic melanoma. Abstract 10523, ASCO 2011 Annual Meeting.

Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAFV600E mutation. N Engl J Med. 2011 Jun 30; 364(26):2507-2516.PubMed 21639808

Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002 Jun 27; 417(6892):949-954.PubMed 12068308

Halait H, DeMartin K, Shah S, et al. The analytical performance of a real-time PCR-based assay for the BRAFV600E mutation used as the companion diagnostic test for the novel BRAF inhibitor vemurafenib (RG7204/PLX4032) in metastatic melanoma. Abstract 2212, AACR 2011 Annual Meeting. Diagn Mol Pathol. 2012 Mar; 21(1):1-8.

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