On January 19, 2021 In an announcement that will help more people with advanced prostate and pancreatic cancers in Japan, Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported that it will receive reimbursement for its BRACAnalysis Diagnostic System, which helps physicians determine whether certain patients will qualify and potentially benefit from treatment with the PARP inhibitor, Lynparza (olaparib) (Press release, Myriad Genetics, JAN 19, 2021, View Source [SID1234574095]). BRACAnalysis was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in October 2020 as a companion diagnostic for these indications and the reimbursement decision is now in effect.

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"BRACAnalysis continues to be the gold standard for germline BRCA1 and BRCA2 testing around the globe," said Nicole Lambert, president of Myriad Genetic Laboratories. "Our goal is to continue to expand patient access to the proven benefits of genetic testing and help physicians combat even the most difficult to treat cancers."

Myriad estimates there are more than 78,000 cases of prostate cancer and 40,000 cases of pancreatic cancer per year in Japan. With the reimbursement decision, approximately 20,000 patients in Japan will now qualify to receive genetic testing. BRACAnalysis was previously approved in Japan to identify patients with ovarian and breast cancer who have a germline BRCA mutation and are eligible for treatment with Lynparza. BRACAnalysis is the only germline test for BRCA1 and BRCA2 mutations to receive regulatory approval in Japan.

"Now that BRACAnalysis is available in Japan to assess the presence of BRCA1 or BRCA2 in deleterious or suspected deleterious mutations, more patients with prostate and pancreatic cancer will have access to advanced options for treatment," said Hiroji Uemura, M.D., Ph.D., Professor, Department of Urology and Renal Transplantation, Yokohama City University Medical Center.

"As physicians, we are excited to use BRACAnalysis to identify those patients who may need those advanced treatments, and to continue improving health outcomes in the fight against those cancers," added Hideki Ueno, M.D., Ph.D., Medical Director, Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital."

Myriad has been collaborating with AstraZeneca since 2007 on the development of companion diagnostics for Lynparza. Lynparza is a trademark of AstraZeneca. Lynparza is jointly developed and commercialized by AstraZeneca and MSD (known as Merck & Co., Inc. in the United States and Canada). Additionally, Myriad has partnered with SRL Inc., a subsidiary of H.U. Group Holdings, Inc. to expand the commercialization of the BRACAnalysis Diagnostic System in Japan.

According to World Cancer Research Fund, pancreatic cancer is the 12th most common cancer worldwide and Japan ranks third in the world for highest rates of incidence, according to the World Health Organization. Additionally, in Japan, prostate cancer is estimated to account for 18% of cancers diagnosed in men, according to the International Agency for Research on Cancer.

About the BRACAnalysis Diagnostic System
BRACAnalysis 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.

About SRL
Since the establishment in 1970, SRL, Inc., a member of the H.U. Group Holdings, Inc., Japan-based leading healthcare group, has been providing comprehensive testing services as the largest commercial clinical laboratory in Japan. SRL carries out nearly 400,000,000 tests per year, covering a wide range of testing services including general/emergency testing, esoteric/research testing, companion diagnostics tests, genomic analysis, and etc. For more information, please visit View Source