In vitro diagnostics provider bioMérieux has announced that its molecular test THxID-BRAF has received pre-market approval from the Food and Drug Administration (FDA) for commercialization in the United States. The test is intended for the qualitative and simultaneous detection of both BRAF V600E and V600K mutations in late stage metastatic melanoma tumor samples. This test is a companion diagnostic designed as an aid to oncologists in selecting melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s (GSK) Tafinlar (dabrafenib), as well as in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist (trametinib).
THxID-BRAF is a real-time PCR test that offers clinicians a standardized, reproducible, and clinically validated method to select patients with BRAF-mutant unresectable or metastatic melanoma that may be suitable for treatment with Tafinlar and Mekinist. Easily integrated into the laboratory, it gives fast and accurate results for confident decisions. The assay was developed by bioMérieux’s global R&D team at the Christophe Mérieux Center for molecular diagnostics research in Grenoble, France. According to company representatives, it is easily integrated into the laboratory and gives fast and accurate results.
This approval marks the result of a fruitful collaboration between GSK and bioMérieux that was initiated in 2010, to develop a companion diagnostic test to detect BRAF V600E and V600K gene mutations found in several cancers, including melanoma. GSK and bioMérieux continue to collaborate on new uses of the THxID-BRAF assay. Read more about clinical diagnostic solutions provided by bioMerieux.
