SALT LAKE CITY, Feb. 15, 2019 — Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced its support of the American Society of Breast Surgeons (ASBrS) new guidelines that recommend all people diagnosed with breast cancer undergo genetic testing with a multi-gene panel.
“We applaud the ASBrS for recognizing important advances in scientific knowledge, and for recommending genetic testing for all people with breast cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “The valuable information provided by genetic testing enhances physicians’ ability to select appropriate precision treatments, personalize care for patients and their families and improve health outcomes.”
These new ASBrS guidelines are based on research recently published by the Targeted Medical Education (TME) Breast Care Network in the Journal of Clinical Oncology. The study demonstrated patients who met existing National Comprehensive Cancer Network (NCCN) clinical testing criteria had similar rates of pathogenic/likely pathogenic hereditary mutations in breast cancer genes (9 percent) as patients who did not meet NCCN criteria (8 percent).
“I am excited by our new ASBrS guidelines and look forward to the day when NCCN updates its guidelines also. The exciting new data demonstrated that about half of patients with breast cancer have clinically-actionable mutations that are being missed when genetic testing is restricted to patients meeting current NCCN guidelines.” said Walton Taylor, M.D., President of ASBrS. In his letter to the membership, he cautioned that “As genetic testing expands, it is important to choose the lab carefully making sure they provide quality testing with accurate results and appropriate follow-up.”
Myriad Genetics has been a leader in hereditary cancer testing for over two decades and Myriad’s myRisk® Hereditary Cancer test is the market leading test for patients trying to understand their hereditary cancer risk. According to the American Cancer Society, 330,000 people are diagnosed with breast cancer annually in the United States, and an estimated 10 percent of these are caused by inherited mutations. Fewer than 10 percent of BRCA1/2 carriers have been identified, and up to 80 percent of individuals at risk have not received genetic testing because they do not meet family history criteria of current testing guidelines. The National Cancer Institute estimates that 35,000 patients with breast cancer have pathogenic BRCA1/2 mutations, but only 30 percent have been identified. Additionally, an estimated 10 to 15 percent of women who test negative for BRCA1/2 mutations have pathogenic variants in other cancer susceptibility genes including: ATM, CDH1, CHEK2, NBN, NF1, PALB2, TP53, STK11 and PTEN.
“Knowledge is power and the new ASBrS guidelines send a strong message to the breast cancer community that genetic testing is appropriate for everyone diagnosed with breast cancer,” said Stacey Tinianov, breast cancer survivor and community engagement and advocacy consultant in Santa Clara, California. “I am optimistic NCCN will consider the evidence and update its breast cancer guidelines to ensure appropriate genetic testing becomes the standard of care and is made broadly accessible.”
About Myriad myRisk® Hereditary Cancer The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 29 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.
About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five strategic imperatives: build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com. Follow Myriad on Twitter via @MyriadGenetics.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris, Foresight and Prequel 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 the recommendation by the American Society of Breast Surgeons (ASBrS) of new guidelines that all people diagnosed with breast cancer undergo genetic testing with a multi-gene panel; the value of the information provided by genetic testing in enhancing physicians’ ability to select precision treatments, personalize care for patients and their families and improve health outcomes; the possibility and timing of NCCN updating its guidelines consistent with the new ASBrS guidelines; 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: 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 decision in the lawsuit brought against us by the Association for Molecular Pathology et al; 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, 2018, 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.
|Media Contact:||Investor Contact:|
|Ron Rogers||Scott Gleason|
|(801) 584-3065||(801) 584-1143|
|[email protected]||[email protected]|