Validation Study Shows Prolaris Test Identifies Men Who May Benefit from Surgery or Radiation at the Time of a Prostate Cancer Diagnosis
SALT LAKE CITY, June 27, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN), a global leader in personalized medicine, today announced publication of results from a large study that demonstrated the Prolaris test can accurately predict the 10-year risk of metastases in men newly diagnosed with localized prostate cancer. The study was published in journal Prostate Cancer and Prostatic Diseases.
“This study demonstrates that the Prolaris test effectively identified those men with localized prostate cancer who progressed to metastatic disease,” said Stephen Bardot, M.D., a study investigator and chairman, Department of Urology Associate Medical Director, Surgical Services at the Oschner Clinic. “Importantly, the Prolaris test provided critical information that can be used to determine which men with localized prostate cancer are candidates for active surveillance and which men should receive definitive therapy with surgery or radiation at the time of diagnosis.”
The large pooled analysis included 1,062 men with localized prostate cancer who were definitively treated with surgery (n=800) or radiation (n=262). The primary objective was to evaluate ability of the Prolaris test (CCP score) and the Prolaris test combined with clinical information (CCR) to predict 10-year risk of progression to metastatic disease. The analysis demonstrated the Prolaris test was the strongest independent predictor of progression to metastatic disease, and men were approximately three times more likely to develop metastatic disease with each unit increase in the Prolaris test score (HR: 2.93; p=1.8x10-11). When the Prolaris test score was combined with clinical information the results were even more highly prognostic, and men were up to four times more likely to develop metastases with each unit increase in the test score (Figure 1: HR: 4.00; p=6.3x10-21).
Figure 1. Prolaris Test Accurately Predicts Risk of Prostate Cancer Progression
“We are excited by these positive study results that advance our understanding of prostate cancer and build on multiple prior studies demonstrating the clinical performance of the Prolaris test,” said Todd Cohen, M.D., board certified urologist and vice president of Medical Affairs, Myriad Urology. “Importantly, these data showed that men with localized prostate cancer and a high Prolaris score were up to four times more likely to develop metastatic disease. This information can help guide treatment planning decisions so that men receive the best care and health outcomes.”
About Prostate Cancer
According the American Cancer Society, more than 165,000 men will be diagnosed with prostate cancer this year. The National Comprehensive Cancer Network (NCCN) medical guidelines for prostate cancer treatment include biomarker testing as an element of clinical care and support Prolaris as standard-of-care to help inform treatment decisions for patients with low and favorable-intermediate risk prostate cancer.
Prolaris is a genetic test developed by Myriad that directly measures tumor cell growth. The Prolaris test paired with both prostate-specific antigen (PSA) and Gleason provides the level of aggressiveness of a patient’s individual prostate cancer. PSA and Gleason only have the ability to identify how far the cancer has progressed thus far. However, when these are combined with a Prolaris test score, patients get an accurate assessment of how aggressively that cancer will progress over the next ten years. 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 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.
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 the Prolaris test providing critical information that can be used to determine which men with localized prostate cancer are candidates for active surveillance and which men should receive definitive therapy with surgery or radiation at the time of diagnosis; the Prolaris test providing information that can help guide treatment planning decisions so that men receive the best care and health outcomes; 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.