Myriad Announces Research Collaboration with University of Leeds
Clinical Utility Study will Evaluate the Prolaris® Test in Men with Prostate Cancer
SALT LAKE CITY, Sept. 16, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, today announced it will collaborate with the Leeds Centre for Personalised Medicine and Health to evaluate the clinical utility of the Prolaris® test in men diagnosed with prostate cancer.
“We are excited to collaborate with Leeds and help improve the outcomes for men with prostate cancer,” said Gary King, executive vice president, International Operations at Myriad. “The Prolaris test will help men with prostate cancer to benefit from advances in genetic testing and personalised treatment plans.”
The study will recruit 100 men and will evaluate the effect of the Prolaris test result on doctors’ and patients’ decisions about treatment and on costs of using the test routinely in the National Health Service. If a man’s Prolaris test result shows that their prostate cancer is low risk, they may choose to avoid or delay having invasive treatment such as surgery or radiotherapy. In addition to the costs, those treatments have associated risks of bowel and urinary problems as well as erectile dysfunction.
“Personalised medicine means taking the approach that when it comes to treatment and care, one size does not fit all,” said Dr. Mike Messenger, head of the Leeds Centre for Personalised Medicine and Health (LCPMH). “This study will explore how healthcare professionals and their patients react to being given more personalised information than usual tests can give about risk. We want to understand whether the Prolaris test results influence what they decide to do next, and if so why and in what way.”
The LCPMH, hosted by the University of Leeds and a project of the Leeds Academic Health Partnership, is coordinating the study. It designed the study in partnership with Leeds Teaching Hospitals NHS Trust, the Leeds Institute of Health Sciences and the University of Leeds.
“Building on the state-of-the-art prostate cancer services offered by Leeds Teaching Hospitals, this exciting study is going to explore the application of what could be next generation of cancer diagnostic testing,” said Mr William Cross, consultant urological surgeon at Leeds Teaching Hospitals NHS Trust. “Hopefully, more personalised diagnostic information will lead to better treatment decisions and outcomes.”
About Prostate Cancer in the UK
Prostate cancer is the most common form of cancer in men in the UK, with nearly 50,000 new cases a year, equivalent to around 130 new cases every day.
Prolaris is a novel RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression 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 progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.
About Myriad Genetics
Myriad Genetics Inc., is a leading precision 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: http://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 related to the planned collaboration with the University of Leeds to evaluate the clinical utility of the Prolaris test in men diagnosed with prostate cancer; the collaboration helping to improve the outcomes for men with prostate cancer; the ability of the Prolaris test to help ensure that men with prostate cancer can benefit from advances in genetic testing and personalised treatment plans; the details and aims for the study; 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, 2019, 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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