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FDA Approves Foundation Medicine CDx Test for Lynparza

NEW YORK – Foundation Medicine said on Monday that the US Food and Drug Administration has approved its FoundationOne CDx test as a companion diagnostic for olaparib (AstraZeneca's and Merck's Lynparza) for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.

The test detects both germline and somatic mutations in BRCA1 and BRCA2 and could help identify more patients who could benefit from Lynparza than tests that only identify germline BRCA mutations, Foundation Medicine said, adding that such tests only detect about half of all BRCA mutations.

FoundationOne CDx, which detects mutations in 324 genes, select gene rearrangements, and genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB), already has FDA approval for use in all solid tumors and incorporates multiple companion diagnostics for a total of 18 FDA-approved targeted therapies.

Foundation Medicine, a subsidiary of Roche, has an ongoing collaboration with AstraZeneca and Merck to develop companion diagnostics for Lynparza in prostate cancer.