Results from second study cite Prolaris® as most clinically significant prognostic parameter of outcomes at time of diagnosis, identifying men who need aggressive hormonal treatment and those who can safely be monitored instead
SALT LAKE CITY, Feb. 12, 2021 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced today additional data further validating the prognostic power of its Prolaris® test and its ability to help accurately predict which men with more aggressive prostate cancer will benefit from intensification of therapy and which patients may safely avoid such treatments. This second validation study was presented during an oral presentation at the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GU) by Jonathan Tward M.D., Ph.D, associate professor in the Department of Radiation Oncology at the University of Utah.
According to estimates by the American Cancer Society, 248,530 new cases of prostate cancer are expected to be diagnosed this year in the U.S. While early screening tests have helped reduce the mortality rate, they can often result in overdiagnosis and overtreatment of a disease that is clinically insignificant. The Prolaris test can more accurately predict the aggressiveness of the cancer allowing for more precise treatment and avoidance of more intense therapies with a patient’s parallel morbidities.
“There are many viable treatment paths for men with prostate cancer,” said Dr. Tward. “This new data helps distinguish the most appropriate personalized treatment path for each patient based on how their specific tumor is behaving. For some men, this means being able to avoid overtreating patients with therapies including hormone treatment that can momentously impact their quality of life, while still appropriately treating their prostate cancer.”
The new data comes from a second study following previous data, recently published in Clinical Genitourinary Cancer in January 2021, that incorporated men treated surgically or with radiation therapy. This new study combined a Prolaris molecular risk score threshold with a clinical model for predicting a patient’s benefit from androgen deprivation therapy. Prolaris determined that about one of every two men with unfavorable intermediate-risk and one of every five men with high-risk prostate cancer are below the proposed threshold associated with aggressive disease and can therefore safely be treated with less intense therapy while maintaining the benefits of treatment. Additional key findings revealed that the Prolaris test was an accurate predictor of progression to metastatic disease.
“Myriad Genetics was the first company to offer a test that directly measures the molecular biology of an individual patient’s prostate cancer,” said Todd D. Cohen, M.D., vice president of Medical Affairs for Urology at Myriad Genetics. “This study by Dr. Tward and his team is another strong validation of the prognostic power of the Prolaris test and our ongoing commitment to providing healthcare professionals with the tools needed to determine the most effective treatments and monitoring strategies for each patient.”
In March 2020, the National Comprehensive Cancer Network updated its professional guidelines to include biomarker testing for unfavorable intermediate and high-risk patients with prostate cancer. With the updated guidelines, Prolaris was one of only two prognostic tests to be considered for those expanded indications. Approximately 60% of men with prostate cancer currently have insurance or Medicare access to Prolaris, and Myriad continues to work toward expanding access so that every man who is facing difficult treatment decisions will be able to utilize the full benefits of the test.
Prolaris is a genetic test developed by Myriad Genetics that directly measures tumor cell growth. The Prolaris test paired with other clinical and pathologic variables provides the level of aggressiveness of a patient’s individual prostate cancer and assesses risk of death or the development of metastatic disease from prostate cancer. For more information visit: www.prolaris.com.
About Myriad Genetics
Myriad Genetics Inc., is a leading genetic testing and precision medicine company dedicated to transforming patient lives worldwide. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, 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 CDx, Vectra, Prequel, Foresight, GeneSight, riskScore 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 related to the validation study presented during at ASCO-GU by Jonathan Tward M.D., Ph.D; expanding access so that every man who is facing difficult treatment decisions will be able to utilize the full benefits of the Prolaris test; 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: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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 decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); 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, 2020, 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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