Myriad Genetics, AstraZeneca Expand Collaboration on Olaparib Phase 3 Clinical Trials
Myriad Genetics, Inc. (NASDAQ: MYGN) announced today that it has entered into an expanded, nonexclusive global collaboration agreement with AstraZeneca (NYSE: AZN) 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.