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Myriad Seeks Japanese Regulatory Approval for its BRACAnalysis® Diagnostic System in People with Advanced Pancreatic and Prostate Cancer
SALT LAKE CITY, March 30, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced
About this update from Myriad Genetics, Inc.
[{"type":"text","content":"SALT LAKE CITY, March 30, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced it has submitted a supplementary application with the Japanese Ministry of Health Labour and Welfare for its BRACAnalysis® Diagnostic System (i.e., “BRACAnalysis”) to be used as a companion diagnostic to help to identify people with metastatic pancreatic or metastatic castration-resistant prostate cancer who have germline BRCA1 and BRCA2 mutations and may be candidates for targeted therapy with the PARP inhibitor, Lynparza® (olaparib), subject to regulatory approval. \n “Today’s regulatory filing potentially will expand the approved indications for BRACAnalsyis as companion diagnostic test in Japan,” said Gary King, executive vice president of International Operations at Myriad. “We look forward to helping people with pancreatic and prostate cancers access precision medicine therapy.”Myriad estimates there are more than 78,000 cases of prostate cancer and 40,000 cases of pancreatic per year in Japan. The BRACAnalysis® Diagnostic System previously was approved in Japan to identify patients with ovarian or breast cancer who have a germline BRCA mutation and are eligible for Lynparza therapy. BRACAnalysis is the only germline test for BRCA1 and BRCA2 mutations to receive regulatory approval in Japan. Myriad has partnered with SRL Inc., a subsidiary of Miraca Group, to commercialize the BRACAnalysis Diagnostic System in Japan. About the BRACAnalysis® Diagnostic SystemBRACAnalysis is a diagnostic system that classifies a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. Variants are classified into one of the five categories; “Deleterious,” “Suspected Deleterious,” “Variant of Uncertain Significance,” “Favor Polymorphism,” or “Polymorphism.” Once the classification is completed, the results are sent to medical personnel in Japan for determining the eligibility of patients for treatment with Lynparza. Myriad has been collaborating with AstraZeneca (LSE/STO/NYSE: AZN) since 2007 on the development of companion diagnostics for Lynparza. Lynparza is a trademark of AstraZeneca Lynparza is marketed by AstraZeneca and MSD (known as Merck & Co., Inc. in the United States and Canada). About SRLSince the establishment in 1970, SRL, I...