Myriad Genetics has entered into an expanded, nonexclusive global collaboration with AstraZeneca to provide companion diagnostics for AZ’s olaparib Phase III development program. Olaparib is an investigational orally active poly-ADP ribose polymerase (PARP) inhibitor being developed for the treatment of various tumor types, including BRCA-mutated breast and ovarian cancers.
Myriad will build a new lab within its Salt Lake City facility in accordance with FDA regulations for companion diagnostic devices. In August, the FDA approved Myriad’s Investigational Device Exemption (IDE) for BRACAnalysis, 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 chief executive officer 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."
"Our hope is that the Phase III 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 Personalized Healthcare and Biomarkers at AZ. "Myriad is well positioned to provide high quality BRCA mutation testing services and the infrastructure to offer testing to support therapy choices."
AstraZeneca, Myriad Genetics Expand Olaparib Pact
Published September 4, 2013
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