Comprehensive Test Helps Identify Women with Advanced Ovarian Cancer Who May Benefit from First-Line Lynparza® Maintenance Treatment
Salt Lake City, UT (GLOBE NEWSWIRE) - Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced that it has received additional reimbursement for its myChoice® Diagnostic System in Japan.
The Myriad myChoice test is the most comprehensive tumor test for determining homologous recombination deficiency (HRD) status caused by a range of mutations in genes such as BRCA1 and BRCA2. It enables healthcare professionals to identify patients with advanced ovarian cancer who are eligible for first-line maintenance treatment with Lynparza (olaparib). This capability benefits BRCAm patients – carriers of harmful mutations in either the BRCA1 or BRCA2 gene (BRCAm) – and patients whose tumors are HRD-positive. Japan’s Ministry of Health, Labour and Welfare approved myChoice as a companion diagnostic for this indication in November 2020, and in addition to the reimbursement for fourth-line treatment in ovarian cancer, reimbursement is now available for use in first-line treatment, as well.
According to the World Cancer Research Fund, ovarian cancer is the eighth most commonly occurring cancer in women. Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%, according to the Ovarian Cancer Research Alliance. For patients with advanced ovarian cancer, the primary aim of first-line treatment is to delay progression of the disease for as long as possible and maintain the patient’s quality of life.
“This most recent approval enables physicians to have additional options available to effectively treat women with advanced ovarian cancer,” said Professor Daisuke Aoki, M.D., Ph.D., Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. “Physicians can now use Myriad myChoice to identify patients that could potentially benefit from maintenance treatment with Lynparza.”
The Myriad myChoice CDx test can be used to identify 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 commonly used in cancer treatment. In August 2020, myChoice was exclusively cited by the American Society of Clinical Oncology in recommendations on the use of PARP inhibitors for the treatment and management of BRCAm and HRD-positive patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology. The myChoice test has also been used in the PAOLA-1 and SOLO-1 trials.
“The use of genetic testing and precision medicine is increasingly important when it comes to guiding treatment for women with advanced ovarian cancer,” said Nicole Lambert, president of Myriad Genetic Laboratories. “The approval and now additional reimbursement of the myChoice test will empower healthcare professionals in Japan to better identify and treat patients who may respond to targeted therapy. Our work with AstraZeneca is another example of how strong collaboration among industry leaders can benefit patients and providers.”
Myriad has been working 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 Merck (known as MSD Inc. outside 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 myChoice Diagnostic System in Japan.
About the myChoice Diagnostic System
Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: https://myriad-oncology.com/mychoice-cdx/
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 other tests. 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 advancing health and wellbeing, empowering individuals with vital genetic insights and enabling healthcare providers to better detect, treat and prevent disease. 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 genetic testing can significantly improve patient care and lower healthcare costs. For more information on how Myriad fulfills its purpose, 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 additional reimbursement for the Company’s myChoice® Diagnostic System in Japan for first-line maintenance treatment of ovarian cancer patients with Lynparza (olaparib); 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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