Myriad's Prolaris® Test Significantly Improves the Risk Classification for One Third of Men Diagnosed with Localized Prostate Cancer
SALT LAKE CITY, Feb. 17, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in personalized medicine, today announced new data demonstrating the utility of the Prolaris® test to more accurately classify mortality risk and guide the management of newly diagnosed men with prostate cancer. The data are being presented at the 2017 Genitourinary Cancers Symposium (ASCO GU) meeting in Orlando, Fla.
"Myriad is pioneering personalized medicine for prostate cancer and is committed to helping men achieve their treatment goals," said Michael Brawer, M.D., vice president of Medical Affairs, Myriad Genetic Laboratories. "We are excited about the new data on prostate cancer reclassification being presented at ASCO GU, which adds to the growing body of evidence supporting the Prolaris test and will help urologists to match treatment options with patients' risk profiles."
Title: Patient NCCN Risk Classification Based on Combined Clinical Cell Cycle Risk (CCR) Score.
Presenter: Steve Stone, Ph.D.
Date: Friday, Feb. 17, 2017: 12:15-1:45 and 6:00-7:00 p.m. ET.
This study evaluated the prognostic information provided by the Prolaris test plus CAPRA (i.e., clinical features) to generate an estimate of prostate cancer mortality within 10 years of diagnosis versus NCCN risk category as determined by clinical features alone. The analysis included data from 16,442 men who received the Prolaris test. Based on clinical features alone, men were classified according to NCCN guidelines as low (n=8,695), favorable intermediate (n=3,347), intermediate (n=3,086) or high risk (n=1,224).
After recalculating the risk of prostate cancer mortality using the Prolaris test plus CAPRA, approximately one third of patients were reassigned to a different 10-year mortality risk category. The specific reclassifications by NCCN category were as follows:
- Low Risk: 25 percent reclassified to favorable intermediate or intermediate risk.
- Favorable Intermediate Risk: 24 percent reclassified to lower and 23 percent to higher risk.
- Intermediate Risk: 24 percent reclassified to lower and 25 percent to higher risk.
- High Risk: 25 percent reclassified to favorable intermediate or intermediate risk.
"Clinical features alone are useful, but as this study illustrates, and was demonstrated by our numerous prior clinical validation studies, the Prolaris test is a powerful and independent predictor of clinical outcome that can substantially improve the risk classification of newly diagnosed men with prostate cancer," said Brawer.
Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #GU17.
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.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, EndoPredict, Vectra, GeneSight 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.
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 data being presented at the at the 2017 Genitourinary Cancers Symposium; the ability of the Prolaris test to more accurately classify mortality risk and guide the management of newly diagnosed men with prostate cancer; the ability to help urologists to match treatment options with patients' risk profiles; 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 described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the 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 tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our 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, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; 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; 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 Annual report on Form 10-K for the fiscal year ended June 30, 2016, 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.
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