The test is an in-vitro diagnostic designed for the qualitative identification of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The product is designed to help the selection of patients with melanoma whose tumours carry the BRAF V600E mutation for treatment with dabrafenib (Tafinlar), as well as those whose tumours carry the BRAF V600E or V600K mutation for treatment with trametinib (Mekinist).
The US FDA authorised these medicines, developed by UK GlaxoSmithKline plc (LON:GSK), and the gene test as a companion diagnostic in May 2013. The drugs are used for the treatment of advanced or unresectable melanoma, while the THxID-BRAF test is manufactured by bioMerieux.
Quest Diagnostics medical director for cancer diagnostics, Dr. Frederic Waldman, commented that the THxID-BRAF test broadens the services the firm offers for melanoma and other cancers across a continuum of care, helping doctors guide treatment decisions and improve health.
Apart from bioMerieux's test, Quest Diagnostics offers the FDA-approved cobas 4800 BRAF V600 Mutation Test, which identifies the BRAF V600E mutation to help the selection of patients for treatment with vemurafenib, an oral drug intended as a therapy of patients whose melanoma tumours harbour the mutation. In addition, the company offers a lab-developed test for the evaluation of BRAF mutations in melanoma, thyroid, and colorectal cancers based on sanger sequencing.
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