FDA approves Myriad’s BRACAnalysis CDx for use with ovarian cancer drug

Dec 22 2014

BRACAnalysis CDx is First and Only FDA-Approved Test to Assess BRCA Status

Myriad Genetics, Inc. (NASDAQ: MYGN) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza™ (olaparib). Lynparza is the first poly ADP-ribose polymerase (PARP) inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic for use with a novel PARP inhibitor.

“Myriad is excited to offer the first and only FDA-approved companion diagnostic for Lynparza, which we believe opens a new door in personalized medicine and represents a big step forward in tailoring treatment for women with ovarian cancer,” said Mark Capone, president, Myriad Genetic Laboratories. “Less than 25 percent of ovarian cancer patients know their germline BRCA status, which is critical for any ovarian cancer patient who may be considered for treatment with Lynparza.”

BRACAnalysis CDx is a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample.  BRACAnalysis CDx was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad’s commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.

“Myriad has proven its ability to navigate a rigorous FDA regulatory approval process
that included a comprehensive review of our DNA sequencing, large rearrangement detection and variant interpretation processes. Patients can be confident their BRACAnalysis CDx test results from Myriad are highly accurate,” said Capone.  “Our scientific excellence, reputation for high quality and regulatory experience are key reasons why Myriad is fast becoming the partner of choice for many biopharmaceutical companies seeking to co-develop companion diagnostic tests.  We hope to expand our collaborations and further diversify our product portfolio.”