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SALT LAKE CITY, June 1, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that AstraZeneca will use Myriad's BRACAnalysis test as a companion diagnostic to stratify patients in AstraZeneca's pivotal Phase 3 clinical studies for olaparib. Myriad has submitted an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for BRACAnalysis testing, which will allow the test to be used as a companion diagnostic to identify potential responders to olaparib therapy in the United States.
"We are pioneers in personalized medicine and believe the future of drug development is using companion diagnostics to identify responders and non-responders to therapy," said Peter D. Meldrum, president and CEO of Myriad. "BRACAnalysis testing has shown significant potential as a companion diagnostic to select which patients will respond to PARP inhibitors, and we look forward to collaborating with AstraZeneca on the clinical program for olaparib."
While Myriad will be replacing the BRACAnalysis test with myRisk Hereditary Cancer™ for hereditary cancer testing, the company plans to offer BRACAnalysis testing as a companion diagnostic -- following review by FDA -- to help select patients who are likely to respond to poly ADP ribose polymerase (PARP) inhibitors, a novel, targeted class of promising cancer therapeutics.
Olaparib is a novel, orally active PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase 2 clinical data presented at ASCO 2013 showed that patients with BRCA mutated ovarian cancers received the greatest clinical benefit from maintenance treatment with olaparib, warranting further study. Based on these data, Myriad will collaborate with AstraZeneca to deliver BRAC testing for its pivotal clinical studies.
"Myriad has a proven track record with high-quality BRAC mutation testing for hereditary breast and ovarian cancer, and we are excited by the potential for BRACAnalysis to be useful as a companion diagnostic that will help clinicians to select cancer patients who are appropriate candidates for receiving olaparib," said Ruth March, vice president and head of Personalised Healthcare and Biomarkers at AstraZeneca.