EndoPredict® Test Receives Positive NICE Recommendation for Patients with Early Breast Cancer
NICE Decision is a Major Milestone in Expanding Access to Patients in the UK
SALT LAKE CITY, Dec. 19, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that the United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE) has included EndoPredict® in its recommendations for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative early breast cancer and who are lymph node-negative.
“I am delighted that NICE has approved the use of EndoPredict to help us decide which breast cancer patients are most likely to benefit from chemotherapy and, equally importantly, which patients can avoid it,” said Mr. Simon Marsh, M.D., FRCS, consultant breast surgeon at Colchester Hospitals University NHS Foundation Trust. “I would envisage that using EndoPredict will increase the quality of care we can give to our patients with breast cancer and it marks another step along the road to truly personalised cancer treatment.”
After an extensive technical review, NICE concluded that the clinical evidence justifies EndoPredict for patients with intermediate risk of distant recurrence as determined by a validated tool such as PREDICT or the Nottingham Prognostic Index. The information provided by the EndoPredict test will help patients choose, with their clinician, whether or not to pursue adjuvant chemotherapy.
“We are excited that NICE has acknowledged the clinical benefits of the EndoPredict test for people with early breast cancer,” said Ralf Kronenwett, M.D., Ph.D., director of International Medical Affairs, Myriad Genetics. “The NICE recommendation is the result of years of hard work and research by many people to advance cancer care for patients in the UK.”
Earlier this month, Myriad presented important new data at the San Antonio Breast Cancer Symposium (SABCS) which demonstrated that EndoPredict is the only test to answer three critical questions for patients: risk of breast cancer recurrence, benefits of chemotherapy and risk of late metastasis to identify patients who can safely avoid extended endocrine therapy. Additionally, academic researchers from the Technical University of Munich presented new prospective outcomes data at SABCS. The key finding is that patients with a high EndoPredict test score had a better outcome with adjuvant chemotherapy compared to endocrine therapy alone.
About Breast Cancer in the United Kingdom
According to Cancer Research UK, 1 in 8 women are still predicted to get breast cancer at some point in their lives. There are approximately 55,000 new cases of breast cancer diagnosed in the UK each year. Of those, it is estimated that approximately 14,000 patients per year are diagnosed with intermediate risk for distant recurrence.
EndoPredict is a third-generation, multigene prognostic test that combines genetic information from the tumor with important clinical features to help clinicians personalize treatment plans for patients with early-stage breast cancer. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive disease and has been used clinically in more than 25,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict is validated to accurately predict both early (0-5) and late (5-15 years) distant recurrence and for prediction of benefit from both adjuvant chemotherapy as well as which patients can safely forgo extended endocrine therapy beyond five years. EndoPredict is manufactured by Myriad Genetics, Inc.
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 critical success factors: build upon a solid hereditary cancer foundation, grow new product volume, expand reimbursement coverage for new products, increase RNA kit revenue internationally and improve profitability with Elevate 2020.
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 Prelude 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.
Oncotype Dx is a registered trademark of Genomic Health, Inc.
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 National Institute for Health and Care Excellence including EndoPredict in its recommendations for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative early breast cancer and who are lymph node-negative; the ability of EndoPredict to answer three critical questions for patients: risk of breast cancer recurrence, benefits of chemotherapy and risk of late metastasis to identify patients who can safely avoid extended endocrine therapy; the finding that patients with a high EndoPredict test score had a better outcome with adjuvant chemotherapy compared to endocrine therapy alone; 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: Ron Rogers
Investor Contact: Scott Gleason