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Quest Adds BioMerieux's BRAF Mutation Test to its Melanoma CDx Offerings

NEW YORK (GenomeWeb) – Quest Diagnostics announced today it will offer BioMérieux's BRAF mutation companion diagnostic for two of GlaxoSmithKline's molecularly targeted melanoma drugs, Tafinlar (dabrafenib) and Mekinist (trametinib).

The US Food and Drug Administration last year approved Tafinlar and Mekinist as treatments for advanced or unresectable melanoma patients whose tumors harbor certain BRAF mutations. Simultaneously, the agency approved BioMérieux's THxID-BRAF companion diagnostic, a real-time PCR assay designed to identify patients whose tumors harbor BRAF V600E and BRAF V600K mutations, and thus are best responders to these agents. Approximately half of melanoma patients have tumors driven by BRAF mutations.

Quest said in a statement that it will offer BioMérieux's test through its Dermpath and Ameripath businesses, which will expand access to more healthcare providers, including dermatologists, oncologists, and hospital pathologists. "Because Quest reaches about half of the practicing physicians and hospitals in the US, patients and providers will now have access to the THxID-BRAF test on a truly broad national scale," Frederic Waldman, medical director of cancer diagnostics at Quest, said in a statement.
In addition to BioMérieux's test, Quest offers Roche's Cobas 4800 BRAF V600 Mutation Test, which gauges which melanoma patients have BRAF V600E mutations and may receive treatment with another skin cancer agent, Zelboraf (vemurafenib). Quest also markets a Sanger sequencing-based laboratory-developed test for assessing BRAF mutations in melanoma, thyroid, and colorectal cancer patients.