New Publication Shows the EndoPredict® Test Identifies Women with Early-Stage Breast Cancer Who Can Forgo Extended Endocrine Therapy
New Study Finds Approximately 62 Percent of Women May Not Need Extended Endocrine Therapy Five Years After Diagnosis
SALT LAKE CITY, May 09, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that the EndoPredict® test (EPclin) identifies women with early-stage breast cancer who can safely forgo extended endocrine therapy five years after diagnosis. Findings from the study were published in the journal Clinical Cancer Research.
“Women with early-stage breast cancer face a critical treatment decision five years after diagnosis, which is whether or not to extend their endocrine therapy,” Ralf Kronenwett, M.D., Ph.D., director of International Medical Affairs, Myriad Genetics. “With the EndoPredict test, we can use a biomarker to help answer that important question, which may improve health outcomes for women and reduce costs for healthcare systems.”
The newly published study assessed the ability of the EndoPredict (i.e., EPclin) test to predict early distant recurrence (0-10 years) and late recurrence (5-15 years) of breast cancer, according to nodal status. The analysis included 1,702 patients with early-stage ER-positive, HER2-negative breast cancer who received five years of endocrine therapy alone. Overall, 62.6 percent of patients had low EndoPredict scores (i.e., <3.3). Women with low EndoPredict scores had a statistically significantly reduced risk of distant recurrence compared to those with high scores (Graph 1). Importantly, EndoPredict was highly predictive of both early and late distant recurrence (DR) in both node-negative and node-positive women.
Graph 1: Women with Low EPclin Scores May Decide to Forgo Extended Endocrine Therapy
“In this study, we demonstrated that women with a high EndoPredict test score are at significantly increased risk of a breast cancer recurrence setback compared to those with a low score,” said Martin Filipits, Ph.D., principle investigator, Institute of Cancer Research, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna Head of ABCSG Research. “Importantly, between 5 and 15 years after diagnosis, only four percent of women in the low-risk group experienced a recurrence, compared to 16 percent in the high-risk group. This suggests that EndoPredict can be used to help select patients with low risk disease, who can safely discontinue endocrine therapy at five years.”
Last month, Myriad published a separate study in the journal Breast Cancer Research and Treatment which demonstrated that the EndoPredict test accurately predicts which women with early-stage ER-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy.
“Women with ER-positive, HER2-negative breast cancer face three critical questions: What is my risk of disease recurrence in the next 15 years?, Do I need adjuvant chemotherapy following my diagnosis?, and Can I discontinue endocrine therapy at the 5-year mark?,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “EndoPredict is the only breast cancer test that answers these questions in a single and affordable offering. It’s one test, three answers. And, nearly all insurance plans in the United States now cover EndoPredict for their members, which is confirmation that we are delivering substantial value to payers.”
About Breast Cancer
One in eight American women will have breast cancer during her lifetime. Breast cancer is the second leading cause of cancer death among American women. The American Cancer Society estimates in its Cancer Facts & Figures 2019 report that more than 268,000 women will be told they have breast cancer in 2019. The World Health Organization estimates the incidence of breast cancer diagnoses in the European Union to be more than 400,000 annually.
EndoPredict is a second-generation, prognostic test that aids personalized treatment planning for patients with early-stage breast cancer. EndoPredict has been validated in over 3500 patients with node-negative and node-positive disease and is the leading breast prognostic in Europe. In contrast to first-generation multigene prognostic tests, EndoPredict incorporates a 12-gene molecular score with known prognostic factors tumor size and nodal status. In clinical studies, EndoPredict demonstrated its robust ability to predict recurrence risk across multiple time-periods: 0-5, 5-10, and 5-15 years. EndoPredict provides clinically actionable information to physicians and patients as they consider the use of adjuvant chemotherapy and extended endocrine therapy.
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 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 clinicians being able to identify women with early-stage breast cancer who can safely forgo extended endocrine therapy five years after diagnosis; the use of EndoPredict test as a biomarker to help answer important questions, or improve health outcomes for women and reduce costs for healthcare systems; the study demonstrating that women with a high EndoPredict test score are at significantly increased risk of a breast cancer recurrence setback compared to those with a low score; EndoPredict’s use to help select patients with low risk disease, who can safely discontinue endocrine therapy at five years; nearly all insurance plans in the United States covering EndoPredict for their members; confirmation that the company is delivering substantial value to payers; 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.