SALT LAKE CITY, Utah, March 3, 2014 - Myriad Genetics, Inc. (Nasdaq: MYGN) today announced that it has published data from the PROCEDE 500 study in the journal Current Medical Research and Opinion, demonstrating that 65 percent of physicians changed their original treatment plans for men with prostate cancer based on results from the Prolaris test. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in 11 clinical studies with more than 5,000 patients.
"Prolaris is an absolute game changer for urologists because it adds meaningful new prognostic information in terms of risk assessment for prostate cancer patients that will improve their care," said E. David Crawford, M.D., head of the Section of Urologic Oncology at the University of Colorado. "In this study, Prolaris led to major changes in therapies with significant reductions or increases in interventional treatments that were based on patients' unique risk profiles."
PROCEDE 500 is a prospective registry study that was designed to evaluate the impact of the Prolaris test on physician treatment recommendations for patients with prostate cancer. In this study of 305 patients, physicians said they would change their treatment plans in 65 percent of cases after receiving the Prolaris report - 40 percent of patients had a reduction in therapeutic burden, while 25 percent had an increase in therapeutic burden - independent of treatment strategy (i.e., surgery and/or radiation vs. active surveillance and/or watchful waiting). These results are summarized in Table-1 and Table-2 below:
Table - 1: Reduction in Therapeutic Burden Among Trial Participants
|Number of Patients in the Study||Number of Patients Who Saw a Reduction in Therapeutic Burden||Percentage Decrease in Therapeutic Burden|
Table - 2: Increase in Therapeutic Burden Among Trial Participants
|Number of Patients in the Study||Number of Patients Who Saw an Increase in Therapeutic Burden||Percentage Increase in Therapeutic Burden|
The study also evaluated the shift in treatment paradigms from interventional to non-interventional and non-interventional to interventional. Those data appear in the Table-3 and Table-4 below:
Table - 3: Planned Interventional Therapy (e.g., Surgery and/or Radiation)
|Number of Patients Planned for Interventional Treatment||Before Prolaris Test Score Number of Patients Planned for Interventional Treatment||After Prolaris Test Score Percentage Decrease in Interventional Therapy|
Table - 4: Planned Non-Interventional Therapy (e.g., Active Surveillance and/or Watchful Waiting)
|Number of Patients Planned for Non-Interventional Treatment||Before Prolaris Test Score Number of Patients Planned for Non-Interventional Treatment||After Prolaris Test Score1 Percentage Increase in Interventional Therapy|
Importantly, in this study there was an overall 50 percent reduction in surgical interventions and a 30 percent reduction in radiation treatment. Additionally, 96 percent of the 24 patients with initial "undecided" treatment regimens selected non-interventional options after receiving the Prolaris score. These results demonstrate that the Prolaris test is associated with high clinical utility among urologists.
"In multiple clinical studies, Prolaris was shown to provide personalized risk of cancer-specific death, metastases or biochemical failure beyond what is achievable with the Gleason score, clinical stage and PSA data," said Michael Brawer, M.D. vice president of Medical Affairs at Myriad Genetic Laboratories. "PROCEDE 500 demonstrates that the Prolaris score significantly enhances treatment plans for men with localized prostate cancer."
Myriad Submits Updated Clinical Dossier for Medicare Reimbursement Myriad also announced that it has submitted the PROCEDE 500 data as part of the Prolaris clinical dossier to the Centers for Medicare & Medicaid Services (CMS) for Medicare reimbursement. As previously disclosed - based on the robust data set from 11 studies with more than 5,000 patients and six publications in peer-reviewed medical journals - the company expects a CMS coverage determination on Prolaris by the end of June 2014.
"More than 30,000 men will die from prostate cancer this year, so there is an urgent need to improve clinical care for patients," said Brawer. "Prolaris adds real value to the healthcare system by reducing unnecessary surgeries or exposure to radiation for men at low risk, while increasing medical interventions for men with aggressive prostate cancer, which we believe will save and improve more lives and potentially save the healthcare system more money."
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 surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 5,000 patients. 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 website: http://www.
Myriad, the Myriad logo and Prolaris, Myriad myPath Melanoma, Myriad myPlan Lung Cancer, Myriad myRisk Hereditary Cancer, 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 the Prolaris clinical study data; data showing that physicians would change their treatment plan for patients with prostate cancer based on Prolaris test results; the Prolaris test as an absolute game changer for urologists by adding meaningful new prognostic information in terms of risk assessment for prostate cancer patients that will improve their care; the effectiveness of Prolaris testing to accurately predict cancer-specific disease progression, including metastases and biochemical recurrence; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are management's present 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 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 companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; risks related to increased competition and the development of new competing tests 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; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic 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 most recent Annual Report on Form 10-K 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.