Myriad Genetics submits premarket approval to FDA for BRACAnalysis

April 15, 2014

Myriad Genetics, Inc., has submitted the first module of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the use of BRACAnalysis testing as a companion diagnostic with olaparib. Olaparib is an investigational, orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca.

“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,” says Mark Capone, president of Myriad Genetics Laboratories. “Our PMA application for BRACAnalysis will provide the FDA with scientific data to evaluate the safety and effectiveness of BRACAnalysis as a companion diagnostic.”

Consistent with the FDA’s modular premarket approval process, Myriad submitted the first of four PMA modules and is working to submit the remaining modules according to a pre-specified plan. The modular approach allows the FDA to review each module as it is received and provides Myriad with timely feedback from the FDA in order to help resolve issues early in the review process.

The collaboration between Myriad and AstraZeneca on olaparib began in 2007. Since then, the two companies have shared scientific insight and worked closely together. In 2012, Myriad made strides in developing BRACAnalysis as a companion diagnostic by retrospectively genotyping patients in a previously completed Phase 2 study of olaparib. This is a good example of how a companion diagnostic can advance the goals of personalized medicine by stratifying patients in a clinical trial. Read more about BRACAnalysis testing.

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