Foundation Medicine Receives FDA Approval of FoundationFocus™ CDxBRCA as a Companion Diagnostic for Rubraca™ (rucaparib) for the Treatment of Women with Ovarian Cancer
–FDA approval of FoundationFocus CDxBRCA marks important progress towards Foundation Medicine’s development of a comprehensive universal companion diagnostic assay across multiple tumor types to advance precision medicine in oncology–
Foundation Medicine, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved FoundationFocus™ CDxBRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib), a therapy developed by Clovis Oncology, Inc., is being considered. FoundationFocus CDxBRCA is an FDA-approved tissue-based, genomic assay that uniquely detects tumor BRCA1 and BRCA2 mutations (may include both germline (inherited) and somatic (acquired)) in ovarian cancer. FoundationFocus CDxBRCA may help identify more women who could benefit from Rubraca therapy as compared to conventional testing methods that only identify germline BRCA1/2 mutations. Germline-only BRCA1/2 testing identifies approximately half of all BRCA1/2 mutations.i,ii
Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.
