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Foundation Medicine Blood Test Gets FDA Approval as CDx for Pfizer's Braftovi in Colorectal Cancer

NEW YORK – Foundation Medicine said Friday that it has received approval from the US Food and Drug Administration for its FoundationOne Liquid CDx assay as a companion diagnostic to Pfizer's Braftovi (encorafenib) in combination with cetuximab in for patients with metastatic colorectal cancer.

The test is now officially approved to identify adult patients harboring a BRAF V600E alteration, which makes them eligible for this targeted therapy and chemotherapy combination. Foundation said that its assay, a comprehensive next-generation sequencing panel, is the only test of its kind to receive CDx approval in this setting. According to the company, the Braftovi-cetuximab combination is also the first and only FDA-approved targeted therapy regimen for adults with BRAF V600E-mutated metastatic colorectal cancer after receiving prior therapies.

FoundationOne Liquid CDx analyzes more than 300 cancer-related genes and has netted FDA approval for several companion diagnostic indications in non-small cell lung cancer, breast cancer, colorectal cancer, and pan-cancer settings.