Myriad Genetics Submits Premarket Approval Application For BRACAnalysis

(RTTNews) - Myriad Genetics, Inc. (MYGN) Monday said it has submitted the first module of a premarket approval application to the Food and Drug Administration for the use of BRACAnalysis testing as a companion diagnostic with olaparib, an investigational drug being developed by AstraZeneca.

BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib.

According to the company, BRACAnalysis is one of the first laboratory developed tests submitted for FDA premarket approval. Myriad submitted the first of four PMA modules and is working to submit the remaining modules according to a pre-specified plan.

"We believe an FDA-approved BRACAnalysis test will provide additional assurance that patients are receiving the most accurate test results and improve patient care by identifying candidates for treatment with olaparib," said Mark Capone, president of Myriad Genetics Laboratories.