Myriad Genetics' PROLARIS Test Accurately Predicts Survival With Prostate Cancer
SALT LAKE CITY, Oct 11, 2010 (GlobeNewswire via COMTEX News Network) -- Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that based on recent clinical validation, its newest molecular diagnostic product, PROLARIS(TM), accurately predicts survival with prostate cancer. The findings were presented at the European Society for Medical Oncology (ESMO) Congress in Milan, Italy. The abstract of the presentation entitled: "Prognostic Value of a Cell Cycle Expression Profile Score Among Men With Conservatively Treated Localized Prostate Cancer" by Jack Cuzick, Ph.D., Cancer Research UK Department of Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, University of London, and colleagues, is now available on the ESMO web site, www.esmo.org.
"This exciting study further demonstrates the potential for PROLARIS to transform the care of prostate cancer patients by leveraging the test's ability to outperform traditional clinical risk factors in the prediction of outcomes in prostate cancer," commented Jerry Lanchbury, Ph.D., Chief Scientific Officer at Myriad Genetics. "These remarkable results are the latest chapter in proving that PROLARIS provides physicians and their patients with critical information about the aggressiveness of the prostate tumor."
The study investigated the ability of PROLARIS to predict death from prostate cancer in a conservatively managed cohort of patients with clinically localized prostate cancer diagnosed by a transurethral resection of the prostate (TURP) between 1990 and 1996. Results demonstrated that PROLARIS accurately predicted prostate cancer death in a cohort of 337 patients with a highly statistically significant p-value = 1x10-21. When compared with the clinical and laboratory measurements traditionally used to manage prostate cancer, the PROLARIS score was the dominant variable in the multivariate analyses (p-value value = 1x10-10). PROLARIS was considerably more informative than Gleason score (a pathology scoring system used to help evaluate the prognosis of men with prostate cancer) and baseline PSA score as well as all of the other prognostic factors.
Twenty-five percent (25%) of the prostate cancer patients had a favorable PROLARIS score and showed a 98.5% chance of surviving their disease over a 10-year period. These patients likely had prostate cancer that was very slow growing and would be candidates for an "active surveillance" strategy. In contrast, prostate cancer patients who received an unfavorable PROLARIS score showed only a 42.4% chance of surviving their disease over a 10-year period. Approximately 25% of the patients had this unfavorable result, indicative of a very aggressive form of prostate cancer that should be treated more aggressively.
PROLARIS consists of a proprietary panel of 46 genes, the majority of which are involved in cell cycle progression and cell growth. PROLARIS examines standard prostate tumor tissue available to pathologists to quantitatively assess whether a patient is likely to have a slow growing form of prostate cancer or a more aggressive cancer. PROLARIS provides clinicians with a direct molecular measure of a prostate tumor's capacity to divide and grow by examining genes that drive tumor growth at the molecular level that can be used to determine a man's risk of dying of prostate cancer. PROLARIS can also be used to estimate the risk of prostate cancer recurrence in patients who have already undergone a radical prostatectomy.
In the United States alone, 218,000 men are diagnosed with prostate cancer each year and may benefit from the information provided by PROLARIS risk recurrence assessment each year.
About Myriad Genetics
Myriad Genetics, Inc. is a leading molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine and prognostic medicine products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
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This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential for PROLARIS to transform the care of prostate cancer patients by leveraging the test's ability to outperform traditional clinical risk factors in the prediction of outcomes in prostate cancer; and PROLARIS results providing physicians and their patients with critical information about the aggressiveness of the prostate tumor. 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 products 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 products in a timely manner, or at all; the risk that licenses to the technology underlying our molecular diagnostic products 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 our products; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our products; the risk of patent-infringement 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 Annual Report on Form 10-K for the year ended June 30, 2010, 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.
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SOURCE: Myriad Genetics, Inc.
CONTACT: Myriad Genetics, Inc. Suzanne Barton, Director, Investor Relations (801) 584-1138 firstname.lastname@example.org
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