On July 1, 2019 Foundation Medicine, Inc. reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for LYNPARZA (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer (Press release, Foundation Medicine, JUL 1, 2019, View Source [SID1234537348]). FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostics. FoundationOne CDx detects tumor BRCA1 and BRCA2 mutations including both germline (inherited) and somatic (acquired) mutations.i FoundationOne CDx may help identify more women who could benefit from Lynparza as compared to conventional testing methods that only identify germline BRCA mutations. Germline-only BRCA1/2 testing identifies approximately half of all BRCA1/2 mutations.ii,iii

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"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," stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. "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."

In December of 2018, AstraZeneca (LSE/STO/NYSE: AZN) and Merck & Co., Inc. announced that the FDA approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.

Foundation Medicine, AstraZeneca and Merck have an ongoing collaboration to support the development of companion diagnostics for Lynparza in prostate cancer.

About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source