bioMérieux, Inc. and Clarient, a GE HealthcareCompany, have announced that bioMérieux‘s molecular diagnostic test ThxID-BRAF has been added to the service offerings provided by Clarient. Clarient will use THxID BRAF in order to aid oncologists in selecting metastatic 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).
The THxID-BRAF test is a companion diagnostic assay developed by bioMérieux, intended as an aid to oncologists in selecting melanoma patients who could benefit from treatments for their tumors which carry the BRAF V600E and V600K mutations. This novel assay received PMA approval from the Food and Drug Administration for commercialization in the United States in 2013. It is a real-time PCR test that, bioMerieux spokespersons say, offers clinicians a standardized, reproducible and clinically validated method for patients with BRAF-mutant unresectable or metastatic melanoma that may be suitable for treatment.
Among cancer patients with metastatic melanoma, approximately half have a BRAF mutation which is an abnormal change in a gene that can enable some melanoma tumors to grow and spread. ThxID-BRAF has been validated for the detection of both the BRAF V600E mutation, which accounts for approximately 85% of all BRAF V600 mutations in metastatic melanoma, as well as detection of the V600K mutation, which represents approximately 10% of all BRAF V600 mutations in metastatic melanoma. Learn more from the product package insert.