Zurich, 21 March 2013 - Myriad Genetics, GmbH. (Nasdaq: MYGN) announced today the European launch of Prolaris®, a 46-gene prognostic test that offers urologists a more accurate way to determine the aggressiveness of prostate cancer. Supported by a growing body of clinical evidence, the molecular diagnostic test was featured in a poster presentation by Dr. David Berman of Johns Hopkins University at the European Association of Urology (EAU) meeting that took place in Milan from the 15th to the 19th of March 2013. The Prolaris test was also the subject of the “Best Poster” award that was presented to Dr. Matthew Cooperberg at EAU in 2012, and a recent publication in the Journal of Clinical Oncology.
“The Prolaris test is an accurate method of identifying which prostate cancers are aggressive, requiring definitive treatment, and which prostate cancers are likely to recur after treatment,” said Gary King, Vice President of International Operations for Myriad Genetics, Inc. “This information is critical for urologists and their patients who are making important treatment decisions prior to and after prostate cancer surgery. Today, most prostate cancer patients undergo aggressive therapy such as prostatectomy and radiation which can have severe short- and long-term side effects. Prolaris can help determine which patients may only need active surveillance, avoiding unnecessary treatment.”
The majority of men diagnosed with prostate cancer in Europe are treated aggressively, although it is estimated that eighty percent have an indolent form of the disease. Aggressive treatment regimens carry significant risks of side effects and have not been shown to provide additional benefit to patients with indolent forms of prostate cancer. Prolaris has been shown to be highly effective in predicting which men have indolent prostate cancer and may be candidates for active surveillance and which men have aggressive prostate cancer and may benefit from definitive treatment such as prostatectomy or radiation.
The poster presentation at EAU 2013 adds to the growing body of clinical evidence supporting the use of Prolaris in evaluating treatment options. More than 1,500 patients have been studied and 2,000 patients are currently in clinical trials involving Prolaris. Four studies have been published in three peer-reviewed publications and additional studies have been presented at scientific forums.
About Prostate Cancer
According to the EAU, prostate cancer is the most common solid tumor cancer in Europe, with an incidence rate of 214 cases per 1,000 men, outnumbering lung and colorectal cancer. In addition, prostate cancer is the second most common cause of cancer death in men. Myriad will introduce Prolaris to urologists and oncologists through its sales force and network of distributors in Europe in the coming weeks.
Prolaris is a genomic risk stratification test developed to aid physicians in predicting prostate cancer aggressiveness in conjunction with clinical parameters such as the Gleason score and PSA. Prolaris is a direct molecular measure of prostate cancer tumor biology. By measuring the expression levels of genes involved with cancer replication, Prolaris is able to more accurately predict disease progression and enable physicians to better define a treatment/monitoring strategy for their patients. Prolaris is significantly more prognostic than currently used clinical/pathologic variables and provides unique additional information that can be combined with other clinical factors to make the most accurate prediction of a patient's cancer aggressiveness and therefore disease progression. Prolaris has been proven to predict clinical progression in four different clinical cohorts, in both pre- and post-treatment scenarios.
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. 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, 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 launch of the Prolaris test in Europe; the introduction of the Prolaris test to urologists and oncologists through the Company’s sales force and network of distributors in Europe; the ability of the Prolaris test to indentify and determine the aggressiveness of prostate cancer recurrence; and the Company’s strategic directives under the captions “About Prolaris” and “About Myriad Genetics.” These “forward-looking statements” are management’s present 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 described in the forward-looking statements. These risks 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; risks related to changes in the governmental or private insurers reimbursement levels for our tests; 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 tests and any future tests 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; 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 claims or challenges to the validity 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.
Scott Gleason, Vice President of Investor Relations
Continuum Health Communications