SALT LAKE CITY and ZURICH, Switzerland, March 20, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that results from the EMPATHY-P clinical study of Prolaris in patients newly diagnosed with prostate cancer will be highlighted at the 30th Annual Congress of the European Association of Urology.
“EMPATHY-P showed that Prolaris provides valuable clinical information that can help physicians improve healthcare and outcomes for their patients with early prostate cancer,” said Colin Hayward, M.D., European medical director, Myriad. “There is no one-size-fits-all treatment approach in prostate cancer. Prolaris provides objective genetic information to help clinicians tailor treatment plans based on patients’ individual risk profiles.”
The EMPATHY-P study evaluated the Prolaris test on 525 patient biopsy samples to determine the aggressiveness of prostate cancer in these newly diagnosed patients from five European countries including: Italy, Germany, Spain, Switzerland and the UK. The patients’ biopsy samples also were evaluated using standard clinical pathology methods (D’Amico/AUA risk stratification), which were then compared to the Prolaris test results.
The EMPATHY-P data showed, overall, that the Prolaris test found 42 percent of the European men evaluated had a risk profile that was either lower or higher than would be expected using clinical pathology. Interestingly, this finding is consistent with the previously published U.S. Prostate Biopsy Research study, which found 51 percent of U.S. patients had a risk profile that differed from clinical pathology. Specifically, EMPATHY-P demonstrated that the Prolaris test score found 22 percent of the European patients had less aggressive prostate cancer and 20 percent had more aggressive prostate cancer compared to standard clinical pathology measurements.
“Prolaris has been shown in multiple clinical studies to be more effective than clinical pathology at determining the aggressiveness of prostate cancer and providing patients with an accurate risk profile based on their own genetic signature,” said Hayward. “Our data showed comparable results for both European and U.S. patients. In both groups, men with a low Prolaris score are good candidates for active surveillance, while patients with a high Prolaris score may need more aggressive care.”
Poster Presentation Details at EAU
| Title: | Poster #321 – European multi-centre study to assess the aggressiveness |
| of prostate carcinoma in newly diagnosed patients using a cell-cycle gene | |
| expression assay. (Prolaris) in biopsy specimens (EMPATHY-P Study). | |
| Presenter: | E. Porpiglia. |
| Date: | Poster Session 26 – Sunday, March 22, 2015, 8:45 a.m. to 10:15 a.m. |
| Room: | Room Paris. |
About Prolaris ®
Prolaris is a novel 46-gene 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 genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.
About Myriad Genetics GmbH
Myriad Genetics GmbH is based in Zurich, Switzerland and is the international subsidiary of Myriad Genetics Inc., 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. For more information on how Myriad Genetics GmbH is making a difference, please visit the Company’s European website: www.myriadgenetics.eu/.
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 is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand internationally. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra 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 EMPATHY-P study data with Prolaris® being featured at the 30th Annual Congress of the European Association of Urology; the ability of the Prolaris test to provide valuable clinical information to help physicians improve care and health outcomes for their patients with prostate cancer; the ability of the Prolaris test to more effectively stratify patients based on their risk profile than clinical pathology; and the Company’s strategic directives under the caption “About Myriad Genetics.” These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing to new testing services, including unexpected costs and delays; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical 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 pharmaceutical and clinical services and any future tests and services 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 our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products 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 or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical 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 Annual Report on Form 10-K for the fiscal year ended June 30, 2014, 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.
CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
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