Foundation Medicine has secured expanded approval from the US Food and Drug Administration (FDA) for its FoundationOneCDx as a companion diagnostic for Lynparza (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer.
Image: The FDA has approved FoundationOneCDx as companion diagnostic for Lynparza. Photo: courtesy of Belova59 from Pixabay.
FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) test for all solid tumours, which integrates multiple companion diagnostics. It can identify tumour BRCA1 and BRCA2 mutations, including both germline (inherited) and somatic (acquired) mutations.
According to the company, FoundationOne CDx is expected to 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 is said to detect around half of all BRCA1/2 mutations.
In December 2018, AstraZeneca and Merck announced that Lynparza secured FDA approval as maintenance treatment for 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 has an ongoing collaboration with AstraZeneca and Merck to support the development of companion diagnostics for Lynparza in prostate cancer.
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device, which will detect of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements.
The test will also detect genomic signatures, including microsatellite instability (MSI) and tumour mutational burden (TMB), using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens.
FoundationOne CDx will also offer tumour mutation profiling, which can be used by qualified health care professionals as per professional guidelines in oncology for patients with solid malignant neoplasms.
Foundation Medicine chief medical officer Dr Brian Alexander 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 tumours,”
“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.”