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TheStreet Open House

Noridian Notifies Myriad Of Initial Draft Decision To Classify Prolaris(R) As A Non-Covered Service

Stocks in this article: MYGN

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. 

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