Myriad Genetics Receives Reimbursement for BRACAnalysis® Diagnostic System in Japan
Patients with Prostate or Pancreatic Cancer to Benefit from Treatment with Lynparza
More Than 20,000 Patients in Japan Now Qualify for Genetic Testing
SALT LAKE CITY, Jan. 19, 2021 (GLOBE NEWSWIRE) -- 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, 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). 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.
“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.
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 https://www.srl-group.co.jp/english/.
About Myriad Genetics
Myriad Genetics Inc., is a leading genetic testing and precision medicine company dedicated to transforming patient lives worldwide. Myriad discovers and commercializes genetic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to more patients in Japan with prostate and pancreatic cancer having access to genetic testing and advanced options for treatment; the number of patients in Japan who will now qualify to receive genetic testing; and the Company’s strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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