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Myriad wins US FDA backing for test related to AstraZeneca, Merck's cancer drug


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Myriad wins US FDA backing for test related to AstraZeneca, Merck's cancer drug

Myriad Genetics Inc. said the U.S. Food and Drug Administration approved its diagnostic test that determines whether patients are eligible to receive AstraZeneca PLC and Merck & Co. Inc.'s ovarian cancer drug Lynparza.

Salt Lake City-based Myriad's diagnostic test BRACAnalysis CDx can now be marketed for identifying patients with advanced ovarian cancer who have a germline, or hereditary, mutation of the BRCA genes and are eligible for first-line maintenance treatment with Lynparza following chemotherapy.

Maintenance therapy is a treatment intended to keep cancer from coming back after initial therapy.

Separately, U.K.-based AstraZeneca and Kenilworth, N.J.-based Merck won FDA approval for Lynparza, also known as olaparib, to treat patients with advanced ovarian, fallopian tube or primary peritoneal cancer after first-line platinum-based chemotherapy had completely eradicated or shrunk the tumors.

Myriad's collaboration with AstraZeneca for a diagnostic test related to Lynparza began in 2007. Myriad estimates that each year, more than 20,000 U.S. patients newly diagnosed with ovarian cancer would qualify for a BRACAnalysis CDx test.