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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.

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