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TEST:
cobas® 4800 BRAF V600 Mutation Test

Company:
Roche
Type:
FDA Approved
Related tests:
The cobas® 4800 BRAF V600 Mutation Test is a real-time PCR assay that detects BRAF V600 mutations in formalin-fixed, paraffin-embedded (FFPET) human tissue. It is designed to help select patients for treatment with vemurafenib alone or in combination with cobimetinib, to treat patients whose melanoma tumors harbor a mutated form of the BRAF gene. Additionally, the test is intended for use with detecting BRAF V600 mutations in papillary thyroid carcinoma (PTC) tissue (not indicated for use in the USA).
Cancer:
Melanoma, Thyroid Gland Papillary Carcinoma
Gene:
BRAF (B-raf proto-oncogene)
Drug:
Cotellic (cobimetinib), Zelboraf (vemurafenib)
Method:
PCR
Approvals
Date
Cancer
Gene
Drug
By
08/17/11
FDA