SALT LAKE CITY, Utah, May 20, 2014 – Myriad Genetics, Inc. (NASDAQ: MYGN) today presented new data from a clinical validation study of Prolaris at the 2014 American Urological Association (AUA) Annual Meeting in Orlando, Fla. The study is the largest validation study to date of any gene-based prognostic test in patients with prostate cancer who were diagnosed by needle biopsy. A key finding was that the Prolaris test accurately differentiated newly diagnosed patients who were likely to die from prostate cancer within 10 years from those with lower-risk disease, which should open the door to more appropriate clinical care for patients at all risk levels. Prolaris is a novel molecular diagnostic test that accurately predicts cancer-specific death and metastases in men with prostate cancer and is a much stronger indicator of clinical outcomes than Gleason score or PSA.
"The aggressiveness of newly diagnosed prostate cancer is variable and difficult to predict. What clinicians really need is a well-validated prognostic test that accurately predicts disease-specific mortality and can improve patient care," said Jack Cuzick, PhD., study investigator and head of the Centre for Cancer Prevention at Queen Mary University of London. "Currently, with standard clinical tools like Gleason Score or PSA, we can't adequately define prognosis. The Prolaris test provides useful new information and is highly prognostic for disease-specific death among men being conservatively treated."
In this study, the goal was to validate the Prolaris test score in 761 conservatively managed prostate cancer patients diagnosed by needle biopsy. The primary endpoint was prostate cancer death and the median follow-up time was 9.5 years. The results showed that for each one unit increase in the Prolaris score, patients had approximately double the risk of dying from prostate cancer (see table).
Data from this study also showed that the Prolaris test is more predictive of mortality than Gleason score, PSA, age, clinical stage or extent of disease individually and almost doubles the total predictive information when they are combined. This study provides additional significant independent validation of the prognostic value of the Prolaris score in conservatively managed patients. The Prolaris test has now been validated in nine cohorts and more than 6,000 patients.
Prolaris Outperforms Upgrading Practice
In the second study featured at AUA, 230 men who had pathologic Gleason Scores of either 3+4 or 4+3 were examined. The Prolaris test was performed on the samples and the rates of biochemical recurrence (BCR) were compared in each group. The results showed that there was no difference in BCR based on an assessment using Gleason Score alone. However, the Prolaris test significantly outperformed the current practice of upgrading to Gleason 3+4 or 4+3 in predicting which patients would experience biochemical recurrence after a radical prostatectomy. These results underscore that genomic tests must be correlated with meaningful oncologic endpoints, rather than endpoints like upgrading. This finding should lead to improved initial decisions on the most effective treatment for each patient based on his personal risk of disease progression.
"Prolaris has been extensively validated in thousands of patients and is the most studied molecular prognostic test for prostate cancer in history," said Michael Brawer, M.D., vice president of Medical Affairs at Myriad Genetics. "Prolaris is rapidly becoming the leading test to assess the aggressiveness of prostate cancer and to help physicians select the most appropriate clinical management for patients newly diagnosed with prostate cancer."
Prolaris Is Strongest Predictor of Metastatic Prostate Cancer
The third study presented at AUA evaluated the prognostic utility of the Prolaris score generated from needle biopsy in men treated with prostatectomy. Importantly, the results of this study found that the Prolaris test was the strongest predictor of metastatic disease compared to other tested clinical variables. Patients with a high Prolaris score have more than a six-fold higher risk of developing metastases compared to patients with a low score. These results confirm that Prolaris may be used at the time of disease diagnosis to better determine which patients are at highest risk and help select appropriate medical care based on their personal risk profiles.
About Prostate Cancer
According to the Centers for Disease Control and Prevention (CDC), prostate cancer is one of the most common cancers among men and is a leading cause of cancer death. Approximately 240,000 cases of prostate cancer are diagnosed and nearly 30,000 men die from the disease annually in the United States.
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. Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 6,000 patients. For more information visit: http://www.prolaris.com.
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 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. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.
Myriad, the Myriad logo, Prolaris, Myriad myPath, Myriad myPlan and Myriad myRisk 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 presentation of Prolaris clinical study data at the 2014 AUA Annual Meeting; data showing that physicians would change their treatment plan of patients with prostate cancer based on Prolaris test results; the effectiveness of Prolaris testing to accurately predict cancer-specific disease progression and mortality when combined with clinical parameters such as Gleason score and PSA; and the Company's strategic directives under the caption "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; risks related to increased competition and the development of new competing tests 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; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic 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 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.
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