FDA approves BRACAnalysis CDx test as companion diagnostic for Lynparza for breast cancer.- Myriad Genetics
Myriad Genetics announced the FDA has approved Myriad’s BRACAnalysis CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) HER2 negative, high-risk early-stage breast cancer who may benefit from Lynparza(olaparib).
RACAnalysis CDx is intended to detect and interpret germline BRCA1 and BRCA2 variants. The test identifies deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer. In the OlympiA trial, patients with HER2 negative early-stage breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants, and high-risk clinicopathological factors had a statistically-significant and clinically meaningful improvement with longer survival, free of invasive or distant disease.
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