The U.S. Food and Drug Administration has approved MyChoice® CDx as the first companion diagnostic test to identify patients with HRD-positive advanced ovarian cancer who can benefit from the PARP inhibitor niraparib.
MyChoice CDx uses advanced genetic sequencing to analyze BRCA1/2 genes and signs of genomic instability, helping find about 34% more eligible patients compared with older testing methods. Niraparib is a once-daily oral drug that works by blocking cancer cells from repairing their DNA, leading to cell death.
The approval is based on results from the PRIMA trial, which showed the test can accurately identify patients who are most likely to benefit from treatment.
The test will be used mainly for two groups: patients with advanced ovarian cancer who respond to platinum-based chemotherapy and are HRD-positive, and patients with recurrent ovarian cancer who carry BRCA mutations and respond to platinum therapy.
This decision highlights a shift toward broader genomic testing in cancer care. By evaluating multiple markers of genomic instability instead of just one, MyChoice CDx allows more patients to access targeted treatments and improves personalized therapy options.