Myriad Announces Positive Results for an EndoPredict® Clinical Study Published in the Journal of the National Cancer Institute
SALT LAKE CITY and COLOGNE, Germany, July 11, 2016 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), in collaboration with researchers from the Institute of Cancer Research in London, today announced positive results for EndoPredict®, a second-generation prognostic gene expression test for breast cancer. The study achieved its primary endpoint by demonstrating that EndoPredict (EPclin) was superior to the first-generation Oncotype DX Breast Recurrence Score® (RS) in predicting the long-term recurrence of ER+, HER2- primary breast cancer. The study was published in the Journal of the National Cancer Institute (JNCI).
"This important study demonstrated that EndoPredict more accurately predicted the recurrence of breast cancer up to 10 years after diagnosis in patients with ER+, HER2- breast cancer than the other test studied," said Jack Cuzick, Ph.D., FRS, director of the Wolfson Institute of Preventive Medicine in London, and an investigator of the study. "These findings will help physicians identify patients who do not need adjuvant chemotherapy following surgery, resulting in a more personalized treatment for their patients."
The analysis included 928 women from the TransATAC study and compared the prognostic power of EndoPredict versus the first-generation test. The primary endpoint of the study was distant relapse-free survival. This analysis showed that EndoPredict markedly outperformed Oncotype DX across the 10-year follow-up period with prognostic power more than four times higher (EPclin: LRX2= 139.3; RS: LRX2=29.1). Using pre-defined cutoffs, EndoPredict and Oncotype DX identified 58.8 percent and 61.7 percent of patients as low risk with hazard ratios for low- versus non-low-risk of 5.9 and 2.7, respectively. Importantly, the authors noted that "EPclin's superior ability to classify patients as low risk was further demonstrated by the similar number of patients classified as low risk by RS coupled with a substantially lower 10-year recurrence rate (5.8% for EPclin vs 10.1% for RS)."
"EndoPredict significantly outperformed the first-generation prognostic test in this head-to-head study, especially for late distant recurrences and in node-positive patients" said Ralf Kronenwett, M.D., chief scientific and medical officer, Sividon. "Additionally, EndoPredict did not classify any patients as intermediate risk, while Oncotype DX classified 28 percent of as intermediate risk which can be confusing for clinicians trying to make treatment decisions."
The JNCI publication can be accessed at: http://jnci.oxfordjournals.org/content/108/11/djw149.abstract.
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EndoPredict is a next-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.com.
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 three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. 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, Vectra 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
Oncotype DX and Oncotype DX Breast Recurrence Score are registered trademarks 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 positive study results for the EndoPredict test for patients with breast cancer; the ability of the EndoPredict test to more accurately predict the recurrence of breast cancer up to 10 years after diagnosis in patients with ER+, HER2- breast cancer than another currently available tests; the superior performance of the EndoPredict test over the Oncotype DX Breast Recurrence Score in predicting the long-term recurrence of ER+, HER2- primary breast cancer; 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; 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, 2015, 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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