SALT LAKE CITY, Oct. 1, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) today announced that BioMarin Pharmaceutical Inc. will use Myriad's BRACAnalysis(R) test in connection with its pivotal Phase 3 clinical studies for BMN 673. BMN 673 is a novel, orally-active PARP inhibitor designed to induce synthetic lethality in BRCA-deficient cells.

Myriad will collaborate with BioMarin to deliver BRAC testing for its pivotal clinical studies. As required by the U.S. Food and Drug Administration, Myriad also submitted an Investigational Device Exemption (IDE) to the FDA that will allow for BRACAnalysis testing to be used as a companion diagnostic to stratify patients in the BMN 673 clinical program. Additional terms of the deal were not disclosed.

"Companion diagnostics are a major focus of our business and are increasingly being integrated into drug development programs," said Mark C. Capone, president of Myriad Genetics Laboratories. "BRACAnalysis has shown promise as a companion diagnostic, and we are actively collaborating with BioMarin to identify responders and non-responders to therapy with BioMarin's novel PARP inhibitor."

"Through our experience working with the Myriad BRACAnalysis test in our Phase 1 trial for BMN 673 in solid tumors, we appreciate the investment that Myriad has made in developing this assay and understanding its use," said Len Post, vice president, Chief Scientific Officer Drug Discovery at BioMarin. "Identifying the right patients to enroll in our Phase 3 study for BMN 673 in BRCA breast cancer will be critical in answering important scientific questions about the safety and efficacy of the compound in this select population."

About BRACAnalysis(R) Companion Diagnostics

BRACAnalysis is the gold standard molecular diagnostic test to confirm the presence of a BRCA1 or BRCA 2 gene mutation. Previously published scientific data have shown that patients with BRCA-mutated cancers may receive clinical benefit from treatment with investigational PARP inhibitors. Myriad Genetics has been developing BRACAnalysis as a companion diagnostic for several years. The Company currently has six active collaborations with pharmaceutical companies to develop a BRACAnalysis as a companion diagnostic for investigational PARP inhibitors. In August, the FDA accepted the first Investigational Device Exemption (IDE) for BRACAnalysis, enabling clinical studies to include BRACAnalysis testing as a companion diagnostic. For more information, visit http://www.myriad.com.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, myRisk are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G

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Excerpt from:
Myriad Genetics and BioMarin Advance PARP Collaboration Into Phase 3

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