Myriad Genetics, Expands Companion Diagnostic Pact with AztraZeneca

Myriad Genetics, a molecular diagnostics company, has expanded its agreement with AstraZeneca to provide companion diagnostics for olaparib, an anticancer drug candidate. Olaparib is an investigational orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca treating various tumor types including BRCA-mutated breast and ovarian cancers. BRCA 1 or BRCA 2 gene mutations are responsible for the majority of hereditary breast and ovarian cancers, according to information from Myriad Genetics.

Under the expanded agreement, Myriad will build out a new laboratory within its Salt Lake City, Utah regulations for companion diagnostic devices. In August 2013, FDA approved an investigational device exemption filed by Myriad, for BRCA analysis, a propretiary gentic test by Myriad for identifying patients with BRCA 1 or BRCA 2 gene mutations to enable clinical studies with olaparib to include BRACAnalysis testing as a diagnostic.

The collaboration builds on an existing agreement through which Myriad provided supply of BRACAnalysis to support the Phase II development program for olaparib in breast and ovarian cancers.