SALT LAKE CITY, Sept. 4, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that it has entered into an expanded, nonexclusive global collaboration agreement with AstraZeneca to provide companion diagnostics for the olaparib Phase 3 clinical development program. Olaparib is an investigational orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca for the treatment of various tumor types including BRCA-mutated breast and ovarian cancers.
Under the expanded agreement, Myriad will build out a new laboratory within its Salt Lake City facility in accordance with U.S. Food and Drug Administration (FDA) regulations for companion diagnostic devices. In August, the FDA approved the Investigational Device Exemption (IDE) for BRACAnalysis ® filed by Myriad, enabling clinical studies with olaparib to include BRACAnalysis testing as a companion diagnostic.
"We are excited to be expanding our companion diagnostic collaboration with AstraZeneca," said Peter D. Meldrum, president and CEO of Myriad. "We are working together to transform the future of personalized medicine and to deliver significant value for patients and the healthcare system, and we are committed to being a leader in companion diagnostics."The collaboration builds on an existing agreement through which Myriad provided supply of BRACAnalysis to support the Phase 2 development program for olaparib in breast and ovarian cancers. Specific terms were not disclosed. "Our hope is that the Phase 3 development program for olaparib will result in a new treatment option for patients suffering from BRCA-mutated ovarian and breast cancers, accompanied by a diagnostic to help physicians identify the patients for whom the therapy might be most appropriate," said Ruth March, vice president and head of Personalised Healthcare and Biomarkers at AstraZeneca. "Myriad is well positioned to provide high quality BRCA mutation testing services and the infrastructure to offer testing to support therapy choices." Olaparib is a novel investigational PARP inhibitor that induces synthetic lethality in homozygous BRCA-deficient cells. Phase II clinical data presented at ASCO 2013 demonstrated that patients with BRCA mutated ovarian cancers received the most clinical benefit from maintenance treatment with olaparib. BRACAnalysis is the gold standard diagnostic test to confirm the presence of a BRCA gene mutation.