SALT LAKE CITY, Utah, Jan. 29, 2014 - Myriad Genetics, Inc. (NASDAQ: MYGN) today announced results from PROCEDE 500, a clinical utility study with its Prolaris test, at the 2014 ASCO Genitourinary Cancers Symposium in San Francisco, Calif. The study demonstrated the significant clinical value of Prolaris to physicians who are treating men with prostate cancer. Prolaris is a prognostic test that accurately predicts prostate cancer-specific death and metastases and has been validated in 11 clinical studies with more than 5,000 patients.
"Prolaris has opened the door to a new era of personalized cancer treatment for men with prostate cancer," said Michael Brawer, M.D. vice president of medical affairs at Myriad Genetic Laboratories. "The Prolaris score is a stronger predictor of prostate cancer death and recurrence than either Gleason score or PSA (prostate specific antigen), and delivers clinically relevant information not provided by any other prognostic test."
PROCEDE 500 is an ongoing prospective registry study designed to examine the clinical utility of Prolaris. Currently, 331 patients have been enrolled and 150 clinicians have completed surveys in 305 cases to assess the influence of the Prolaris score on clinical decision making. Results for these interim data show that in 65 percent of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score. In 40 percent of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting. In 25 percent of cases, physicians increased treatments including the use of surgery or radiation, and in 35 percent of cases, physicians did not change their treatment plans. Full results from PROCEDE 500 have been submitted to a peer-reviewed medical journal for publication.
"As a clinical researcher, I advocate for evidence-based medicine. The Prolaris test score accurately tells me if a patient has an aggressive prostate cancer or not and guides my treatment decisions," said Ashok Kar, M.D., St. Joseph's Hospital in Orange, Calif. "As a practicing physician, I must ask the same question for every patient; should I use surgery or radiation, or should I use active surveillance and watchful waiting? Prolaris helps me answer this critical clinical question."
Prolaris is a novel 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 31 genes related to the progression of tumor cell division. 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 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 presentation of Prolaris clinical study data at the 2014 ASCO Genitourinary Cancers Symposium; data showing that physicians would change their treatment plan of patients with prostate cancer based on Prolaris test results; the effectiveness of Prolaris testing to accurately predict cancer-specific disease progression and mortality when combined with clinical parameters such as Gleason score and PSA; 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.