SALT LAKE CITY, Sept. 24, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Noridian, the Medicare Administrator for Utah, has notified Myriad of its intent to add the Company's prostate prognostic test, Prolaris®, to its next draft Non-Covered Service LCD (local coverage determination). Noridian will solicit public and provider comment on the Prolaris test before making a final decision.
During the public comment period, Myriad will review the draft LCD with Noridian to underscore the role of the test as a molecular staging diagnostic that guides therapy for prostate cancer patients. Myriad is dedicated to ensuring patients and physicians have access to the critical prognostic information provided by the Prolaris test and therefore will provide additional clarity on how the test is currently being used for medical management of patients with prostate cancer.
"One of the major challenges in prostate cancer is determining who is at high risk of progression, which has led to the controversy about over-treatment," said E. David Crawford, M.D., distinguished Professor of Surgery, Urology and Radiation Oncology at the University of Colorado. "What is desperately needed is a test that will more accurately determine an individual's prostate cancer malignant potential. I have had experience with the test and have found Prolaris to be a significant step toward enabling the clinician to more confidently advise the patient in making an appropriate medical decision. It is important that patients have access to this cutting edge test to be able to better select appropriate treatment for their prostate cancer."
In four clinical studies on approximately 1500 patients, the Prolaris test was shown to be a highly significant and accurate predictor of the aggressiveness of a man's prostate cancer. Two of the clinical studies demonstrated that the Prolaris test accurately predicted a patient's risk of biochemical recurrence of disease and the other studies predicted ten year survival rate in patients whose prostate cancer was monitored under a watchful waiting approach. Studies were performed on radical prostatectomy, transurethral resection of the prostate (TURP), and biopsy tissue. At diagnosis, Prolaris was the strongest single predictor of prostate cancer specific mortality. Today, the test is available to assist patients and physicians in medical management decisions for both pre-treatment and post-treatment patients.
"There is a strong and unmet immediate medical need for a personalized prognostic medical management tool like the Prolaris test to assess the aggressive nature of patients' prostate cancer," said Michael Brawer, Vice President of Urological Medical Affairs for Myriad Genetic Laboratories, Inc. "We are committed to working closely with Noridian, as well as other payors, as we believe every man diagnosed with prostate cancer, and his physician, should have access to this clinically critical information."
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 portfolio of 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: www.myriad.com
Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. 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 process for approval for reimbursement of the Prolaris test; Noridian's solicitation of public comments on the Prolaris test; the Company's review with Noridian of the role of the Prolaris test as a molecular staging diagnostic that guides therapy for prostate cancer patients; the Company providing clarity on how the Prolaris test is currently being utilized; whether the Prolaris test will be approved for reimbursement; 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 existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; 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 and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; 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 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; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement and invalidity claims or challenges of our patents; 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 in 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.