Myriad Receives FDA Approval of myChoice CDx® as Companion Diagnostic for Lynparza™ (olaparib) In Patients with Advanced Ovarian Cancer

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[{"type":"text","content":"SALT LAKE CITY, May 11, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) approved the myChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab. Lynparza (olaparib) is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and Merck, known as MSD outside of the U.S. and Canada. \n “We congratulate AstraZeneca and Merck on obtaining another FDA approval of Lynparza for women with advanced ovarian cancer,” said Nicole Lambert, president of Myriad Oncology and Women’s Health. “The approval of the myChoice CDx test will help clinicians quickly identify the potential one in two women whose ovarian cancer is HRD positive and who will likely respond to targeted therapy.” myChoice CDx is the most comprehensive HRD test and identifies people with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as PARP inhibitors. In the PAOLA-1 trial, which compared the efficacy of Lynparza in combination with bevacizumab versus bevacizumab alone, enrolled patients were tested by the myChoice CDx test. “The approval of the myChoice CDx test builds on our shared goal with Myriad to accelerate precision diagnosis and treatment for women with advanced ovarian cancer,” said Ruth March, senior vice president, Precision Medicine, AstraZeneca. “We are excited that women with advanced ovarian cancer who test positive for HRD with the myChoice CDx test at time of diagnosis can now access Lynparza in the first-line maintenance treatment setting in combination with bevacizumab.” Myriad has been collaborating with AstraZeneca since 2007 on the development of companion diagnostics for Lynparza. Lynparza is a trademark of AstraZeneca. About Ovarian CancerOvarian cancer is the eighth most common cause of death from cancer in women worldwide. In 2018, there were nearly 300,000 new cases diagnosed and around 185,000 deaths. Most women are diagnosed...

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