Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Billions for Antivirals

The US is putting $3.2 billion toward a program to develop antivirals to treat COVID-19 in its early stages, the Wall Street Journal reports.

NFT of the Web

Tim Berners-Lee, who developed the World Wide Web, is auctioning its original source code as a non-fungible token, Reuters reports.

23andMe on the Nasdaq

23andMe's shares rose more than 20 percent following its merger with a special purpose acquisition company, as GenomeWeb has reported.

Science Papers Present GWAS of Brain Structure, System for Controlled Gene Transfer

In Science this week: genome-wide association study ties variants to white matter stricture in the brain, and more.