Foundation Medicine gets FDA approval for additional FoundationOne®CDx indication


The FDA has awarded approval to Foundation Medicine for FoundationOne®CDx to be used as a companion diagnostic for LYNPARZA® (olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer. This comprehensive genomic profiling test for all solid tumors that incorporates multiple companion diagnostics detects tumor BRCA1 and BRCA2 mutations both inherited and acquired, and has the potential to detect more women who could benefit from Lynparza versus conventional testing methods that only identify inherited BRCA mutations.

“Foundation Medicine gets FDA approval for additional FoundationOne®CDx indication.“

Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer, said: “Foundation Medicine is proud to receive FDA approval for another important companion diagnostic on FoundationOne CDx, our broad companion diagnostic test that is clinically and analytically validated for all solid tumors. It is imperative that women with advanced ovarian cancer receive rigorous testing for BRCA1/2 mutations such as FoundationOne CDx, which includes both germline and somatic mutations, to determine if they are a candidate for PARP inhibitors.”

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