Date: 2013-05-31
Type of information:
Product name: THxID-BRAF
Compound: real-time PCR test for the simultaneous detection of both BRAF V600E and V600K mutations
Therapeutic area:
Action mechanism:
Company: bioMérieux (France)
Disease: metastatic melanoma
Latest news: * On May 30, 2013, bioMérieux, a world leader in the field of in vitro diagnostics, has announced that its novel molecular test THxIDTM-BRAF received Pre Market Approval (PMA) from the FDA for commercialization in the United States. This test is intended for the qualitative and simultaneous detection of both BRAF V600E and V600K mutations in late stage metastatic melanoma tumor samples. This companion diagnostic has been designed as an aid to oncologists in selecting melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with Tafinlar® (dabrafenib) as well as in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist® (trametinib).This novel assay was developed by bioMérieux’s global R&D team at the Christophe Mérieux Center for molecular diagnostics research in Grenoble, France.This approval marks the result of a fruitful collaboration between GSK and bioMérieux. It 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.
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Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-05-30
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Favourable opinion USA:
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Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
