The FDA has approved an expanded indication for Foundation Medicine’s FoundationOne®CDx, authorizing the test as a companion diagnostic for the AstraZeneca/Merck & Co. co-developed Lynparza (olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer.
FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostics.
The CGP test is a next-generation sequencing based in vitro diagnostic device designed to detect 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 was created to detect tumor BRCA1 and BRCA2 mutations, including both germline (inherited) and somatic (acquired) mutations.
According to Foundation Medicine, the test may help identify more women who could benefit from Lynparza compared to conventional testing methods that only identify germline BRCA mutations—which according to a 2010 study and a 2013 study cited by the company identify only about half of all BRCA1/2 mutations.
“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.
Foundation Medicine partners with AstraZeneca and Merck in an ongoing collaboration to develop companion diagnostics for Lynparza in prostate cancer.
FoundationOne CDx is one of two approved companion diagnostics for Lynparza, according to the FDA. The other is Myriad Genetics’ BRACAnalysis CDx, approved for use in breast cancer and ovarian cancer.
Lynparza won FDA approval in December 2018 as maintenance treatment in adults 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.
Lynparza is one of 18 FDA-approved targeted therapies for which FoundationOne CDx is approved as a companion diagnostic.
In March 2018, FoundationOne CDx won a final National Coverage Determination (NCD) from the Centers for Medicare & Medicaid Services (CMS), allowing Medicare and Medicare Advantage patients to be reimbursed for next generation sequencing (NGS) testing across all solid tumors with the CGP assay.
The final NCD expanded patient eligibility for Medicare reimbursement beyond the draft coverage determination reached by CMS in November 2017—a decision reached following a concurrent review of FoundationOne CDx by the FDA, through the agencies’ Parallel Review Program.
In June 2018, Roche expanded its majority stake in Foundation Medicine into full ownership of the cancer-focused molecular diagnostics developer by acquiring all outstanding shares of the company for $2.4 billion.