Findings Show EndoPredict Was Significantly More Cost Effective than Oncotype DX™
SALT LAKE CITY, June 25, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN), a global leader in personalized medicine, today announced that The Pharmacogenomics Journal published the results of the first comprehensive cost-effectiveness analysis of the EndoPredict® test compared to other breast cancer assays. The key finding is that EndoPredict test was more than twice as cost effective as Oncotype DX®. Breast cancer is the most common cancer in women worldwide.
“Payers would benefit from understanding the financial implications of using gene expression tests to determine recurrence risk in women with early-stage breast cancer,” said Malek B. Hannouf, Ph.D., lead investigator, London Health Sciences Centre, Ontario, Canada. “Our study provides firm evidence validating the economic value of incorporating EndoPredict into patient care.”
This study examined the cost effectiveness of incorporating gene expression testing into standard practice using data from the Anastrozole or Tamoxifen Alone or Combined (ATAC) clinical trial and cost data from the London Regional Cancer Program and other Canadian sources. The analysis evaluated three genetic tests compared to the clinicopathological (CP) features traditionally used to guide adjuvant treatment decisions. The primary endpoint was quality adjusted life years (QALY), which is a measure of the value of health outcomes. The results show that compared to the CP predictors alone-based strategy, EndoPredict was the single most cost-effective genetic test ($36,274/QALY) and was more than twice as cost effective as the market leading Oncotype DX test ($74,911/QALY).
“These results advance our understanding of precision medicine for women with breast cancer and confirm that EndoPredict is the most cost effective genetic test,” said Ralf Kronenwett, M.D., Ph.D., director of International Medical Affairs, Myriad Genetics. “The findings build on prior studies that demonstrated the clinical utility EndoPredict for predicting which women will benefit from adjunctive chemotherapy at diagnosis and who is unlikely to benefit from extended endocrine therapy five years after diagnosis.”
EndoPredict is a second-generation, multigene prognostic test that aids personalized treatment planning 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 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.
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.
Oncotype DX is a 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 relating to benefits to payers from understanding the financial implications of using gene expression tests to determine recurrence risk in women with early-stage breast cancer; the economic value of incorporating EndoPredict into patient care; 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.