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FDA Approves BioMerieux's BRAF Test as CDx

NEW YORK (GenomeWeb News) – The US Food and Drug Administration announced on Wednesday the approval of a companion diagnostic for two drugs that treat patients with advanced or unresectable melanoma.

The FDA approved the drugs from GlaxoSmithKline called Tafinlar (dabrafenib) and Mekinist (trametinib) with the THxID BRAF test from BioMérieux. The PCR-based BRAF test is for determining whether a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene and is the second companion diagnostic approved by the agency for BRAF mutation detection following the approval of Roche's cobas 4800 BRAF V600 Mutation Test in August 2011.

Approval of the BioMérieux test is based on data from clinical studies that supported the approvals of Tafinlar and Mekinist, FDA said.

"The co-approval of Tafinlar and Mekinist and the second companion diagnostic for BRAF mutation detection demonstrates the commitment of pharmaceutical and diagnostic partners to develop products that detect and target the molecular drivers of cancer,” Alberto Gutierrez, director of the Office of In Vitro Diagnostic Devices and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.

Citing statistics from the National Cancer Institute, FDA said that 76,690 Americans will be diagnosed with melanoma this year, and 9,480 will die from the cancer.

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