SALT LAKE CITY, Mar 8, 2010 (GlobeNewswire via COMTEX News Network) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today said data that provides further clinical validation supporting its newest molecular diagnostic product, PROLARIS(TM), was recently presented at the 2010 Genitourinary Cancers Symposium in San Francisco. The abstract of the presentation entitled: "Cell Cycle Genes Predict Recurrence After Radical Prostatectomy" by Gregory P. Swanson, M.D., University of Texas Health Science Center San Antonio, and colleagues is now available on the American Society of Clinical Oncology's website, www.asco.org.
The study examined a well-described cohort of patients for which 10-year follow-up data were available following prostatectomy surgery. The study was carried out by Dr. Swanson and colleagues at the Scott and White Clinic, Temple, Texas and demonstrated that the PROLARIS molecular diagnostic test is a significant predictor of prostate cancer recurrence in training (p=0.01) and validation cohorts (p=0.00000006). In patients with Gleason scores (the most widespread method of prostate cancer tissue grading) below 7, PSA levels (protein produced by cells of the prostate gland) of less than 30ng/ml and with disease confined to the prostate, the PROLARIS test accurately identified those patients who had a low risk of disease recurrence with 95% certainty. In contrast, patients with a high-risk signature had a recurrence risk more than 4-fold higher than those with a low-risk signature. In the validation cohort, PROLARIS was also prognostic in patients with Gleason scores above 6, PSA levels of greater than 30ng/ml and with evidence of disease outside the prostate (p=0.0026).
"These exciting scientific findings provide further support of our new PROLARIS molecular diagnostic test and should have significant clinical impact for prostate cancer patients and their physicians," commented Jerry Lanchbury, Ph.D., Chief Science Officer at Myriad Genetics. "We believe that the PROLARIS diagnostic has the potential to transform the care of prostate cancer patients and that future studies that focus on patients who have not yet undergone surgery will further extend the test's potential clinical utility."
In the United States, approximately 80,000 men undergo a radical prostatectomy (removal of the prostate gland and some surrounding tissue) each year. Approximately 35% of those men will eventually have a biochemical recurrence indicating the return of their cancer. PROLARIS is designed to offer urologists an accurate and objective way of determining an individual's recurrence risk, beyond current clinical assessment techniques. Patients at higher risk of recurrence are candidates for more intensive screening and therapeutic strategies given the aggressiveness of their cancers. Patients at lower risk of recurrence are good candidates for "watchful waiting."
PROLARIS consists of a panel of 46 genes, the majority of which are involved in cell cycle progression. PROLARIS examines standard prostate tumor material available to pathologists to quantitatively estimate the risk of cancer recurrence in patients who have undergone a radical prostatectomy. For the first time, 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. In the United States alone, 80,000 prostate cancer patients may benefit from the 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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Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that these exciting scientific findings will provide further support of the Company's PROLARIS molecular diagnostic test and have significant clinical impact for prostate cancer patients and their physicians; the belief that the PROLARIS diagnostic test has the potential to transform the care of prostate cancer patients and that future studies that focus on patients who have not yet undergone surgery, will further extend the test's potential clinical utility; the ability and extent to which the PROLARIS diagnostic test 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; and the ability and extent to which the PROLARIS diagnostic test is a significant predictor of prostate cancer recurrence. 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, 2009,which has been 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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