Foundation Medicine Garners FDA Approval for Companion Device for Rubraca

The FDA has granted approval to Foundation Medicine’s FoundationFocus CDxBRCA to aid in identifying women with ovarian cancer who are treated with Rubraca.

The device is a tissue-based, genomic assay that detects tumor BRCA1 and BRCA2 mutations in ovarian cancer.

FoundationFocus CDxBRCA is an assay developed from the quality systems regulations - compliant version of Foundation Medicine’s CGP assay. — Cynthia Jessup