The FDA has approved Myriad Genetics’ BRACAnalysis CDx for use with AstraZeneca’s ovarian cancer drug Lynparza (olaparib).

The approval represents a big step forward in tailoring treatment for women with ovarian cancer, says Myriad President Mark Capone. "Less than 25 percent of ovarian cancer patients know their germline BRCA status, which is critical for any ovarian cancer patient who may be considered for treatment with Lynparza,” he says.

Lynparza is a poly ADP-ribose polymerase inhibitor for patients with germline mutations in BRCA 1 and BRCA 2 ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx uses blood samples to detect mutations in the BRCA 1/2 genes and, in clinical studies, successfully identified patients with these mutations who would be candidates for the drug.

The test is the result of a multi-year collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer. Myriad says it is working with other biopharmaceutical companies to evaluate BRACAnalysis CDx as a companion diagnostic with other PARP inhibitors and chemotherapy drugs, and for use in other tumor types. — Kellen Owings

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