Myriad Genetics expands companion diagnostic collaboration with AstraZeneca

RACAnalysis CDx™ Will Be Used in Clinical Trial of Patients with Pancreatic Cancer

Myriad Genetics, Inc. (Nasdaq: MYGN) today announced the expansion of its companion diagnostic collaboration with AstraZeneca. Under the terms of the expanded agreement, Myriad’s BRACAnalysis CDx test will be used to prospectively identify which patients with metastatic pancreatic cancer may respond to treatment with Lynparza™ (olaparib).

Lynparza is a PARP (poly-ADP ribose polymerase) inhibitor being developed by AstraZeneca.  More than 48,000 people are diagnosed with pancreatic cancer and more than 40,000 will die from the disease each year in the United States.

“Pancreatic cancer is one of the few cancers for which survival has not improved substantially in the last 40 years, and the average life expectancy after diagnosis with metastatic disease is three to six months,” said Mark Capone, president, Myriad Genetic Laboratories. “Our collaboration with AstraZeneca is a big step forward in the fight against pancreatic cancer and in ensuring that personalized medicine becomes reality. BRACAnalysis CDx has the potential to quickly and accurately identify those patients who may be candidates for treatment with Lynparza and hopefully to accelerate better health outcomes.”

In December 2014, the U.S. Food and Drug Administration (FDA) approved BRACAnalysis CDx to identify ovarian cancer patients with germline mutations in BRCA1/2 who may be appropriate for treatment with Lynparza. The approval of BRACAnalysis CDx was the first time the FDA has approved a complex laboratory developed test (LDT) under the premarket approval application process and was the first-ever approval of an LDT companion diagnostic test.