SALT LAKE CITY, Utah, Dec. 2, 2014 - Myriad Genetics, Inc. (NASDAQ: MYGN) today announced that clinical data from three studies with Prolaris in prostate cancer patients will be highlighted at the 2014 Society of Urologic Oncology (SUO) Annual Meeting being held tomorrow in Rockville, Md. The new data show that the Prolaris test could save the healthcare system $6 billion over 10 years and that physicians are using the test appropriately to personalize treatment options for their patients.
"Improving patient care is our highest priority, and we strive to prevent the overtreatment of men with low-risk prostate cancer and the under treatment of high-risk patients," said Michael Brawer, M.D., vice president of Medical Affairs, Myriad. "Based on the new data and our prior studies, it is clear that the Prolaris test improves health outcomes, reduces healthcare costs and aids physicians in providing clinical care for their patients."
In a study that evaluated the economic impact of the Prolaris test, researchers found the test reduced costs by $2,850 per patient tested, which over a 10-year period could save the healthcare system $6 billion. For a health plan of approximately 30 million members, this would translate into more than $48 million in savings. It is estimated that two-thirds of these savings would be achieved in the first year after testing. The cost savings were driven by more use of active surveillance in low- and intermediate-risk patients and from lower disease progression rates in high-risk patients who received more extensive treatment.
The Company also will present interim results from PROCEDE 1000, which is the largest prospective clinical utility study to date that evaluates the impact of the Prolaris test on personalizing prostate cancer treatment. The interim data analysis of 816 patients demonstrated that physicians changed their treatment decisions in 44 percent of cases based on results from the Prolaris test. In 32 percent of patients, the Prolaris test score led to a reduction in treatment, while 12 percent of patients received more aggressive treatment based on their test score.
Additionally, the Company will present a clinical study that validates an active surveillance threshold for Prolaris in 585 conservatively managed men with localized prostate cancer. The clinical endpoint for the study was prostate cancer mortality. The results showed that there were no observed cancer deaths in patients who fell below the defined threshold. In a separate analysis of 1,718 patients from a commercial cohort, approximately 55 percent of the patients qualified for active surveillance based on the threshold.
"The validation of an active surveillance threshold will help us identify many more men who are good candidates for surveillance than appear to be based on their clinical features alone. For men considering deferred treatment, falling below the threshold will give them confidence that active surveillance is a realistic option instead of a more aggressive treatment," said Brawer. "Prolaris is rapidly becoming the leading molecular prognostic test to determine if patients have aggressive prostate cancer or not and to help physicians personalize treatment decisions."
2014 SUO - Poster Presentations
Title: Evaluation of the Economic Impact of the CCP Assay in Localized Prostate Cancer.
Presenter: E. David Crawford
Date: Wednesday, Dec. 3, 4:30 p.m. to 6:00 p.m. ET
Title: Impact of CCP Test on Personalizing Treatment Decisions: Results from a Large Prospective Registry of Newly Diagnosed Prostate Cancer Patients.
Presenter: Mark Gonzalgo
Date: Wednesday, Dec. 3, 4:30 p.m. to 6:00 p.m. ET
Title: Validation of an Active Surveillance Threshold for the CCP Score in Conservatively Managed Men with Localized Prostate Cancer.
Presenter: Steven Stone
Wednesday, Dec. 3, 4:30 p.m. to 6:00 p.m. ET
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. 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: http://www.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's websites: http://www.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. 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 clinical data from three studies with Prolaris in prostate cancer patients being highlighted at the 2014 Society of Urologic Oncology (SUO) Annual Meeting; the potential of the Prolaris test to save the healthcare system $6 billion over 10 years; the projected ability of the Prolaris test to reduce costs by $2,850 per patient tested, saving the healthcare system $6 billion; the potential of the Prolaris test to save a health plan of approximately 30 million members more than $48 million, with an estimated two-thirds of these savings potentially achieved in the first year after testing; the Company presenting interim results from PROCEDE 1000 at the 2014 Society of Urologic Oncology (SUO) Annual Meeting, which is the largest prospective clinical utility study to date that evaluates the impact of the Prolaris test on personalizing prostate cancer treatment; the Company presenting a clinical study that validates an active surveillance threshold for the Prolaris test in 585 conservatively managed men with localized prostate cancer; the validation of an active surveillance threshold helping to identify many more men who are good candidates for surveillance than appear to be based on their clinical features alone; falling below the threshold giving men considering deferred treatment confidence that active surveillance is a realistic option instead of a more aggressive treatment; Prolaris rapidly becoming the leading molecular prognostic test to determine if patients have aggressive prostate cancer or not and to help physicians personalize treatment decisions; and the Company's strategic directives under the caption "About Myriad Genetics." 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 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, including unexpected costs and delays; 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 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; 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; 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 Annual Report on Form 10-K for the fiscal year ended June 30, 2014, 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.