Myriad's Prolaris(R) Test Guides Treatment Decisions for Men with Prostate Cancer
Company Presents Data from Four Clinical Studies on Prolaris
SALT LAKE CITY, Dec. 4, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced it will present data from four clinical studies with Prolaris at the 14th Annual Meeting of the Society for Urologic Oncology (SUO) in Bethesda, Md. Prolaris is a prognostic test that accurately predicts cancer-specific disease progression and mortality based on an analysis of 46 cell cycle progression genes. The Prolaris score has been demonstrated to be a stronger predictor of prostate cancer recurrence and cancer-specific
death than clinical parameters such as Gleason score and PSA.
In addition to compelling data on the clinical utility of Prolaris in changing treatment plans for men with prostate cancer, the Company will present data from two new clinical studies on the Prolaris test. These studies further demonstrate the ability of the Prolaris test to accurately stratify a prostate cancer patient's risk of having an aggressive form of the disease. Prolaris has now been validated in 11 clinical studies in approximately 5,000 patients with prostate cancer. Another new study in renal cell carcinoma also will be presented at the SUO meeting, demonstrating that Myriad's cell cycle progression gene panel predicts metastatic progression in patients with this deadly cancer.
"A major challenge for physicians treating men with prostate cancer is knowing whether a prostatectomy or other type of treatment is necessary, or if active surveillance is appropriate," said Michael Brawer, M.D. vice president of Medical Affairs at Myriad Genetic Laboratories. "Our data demonstrate the utility of Prolaris in helping physicians determine the most appropriate and effective treatment for each individual patient based on the aggressiveness of their cancer."
Clinical Utility of Cell Cycle Progression Genes in Facilitating Prostate Cancer Treatment Decisions. [Shore et al., Poster Session II: Dec. 6, 2013, 4:30 p.m. ET]
The prostate biopsy research study evaluated Prolaris' potential clinical utility in guiding the treatment decision for patients diagnosed with prostate cancer. Participating physicians were asked to assess the value of the Prolaris score and questionnaires were completed for 294 evaluable patients with localized prostate cancer. Physicians indicated that 55 percent of tests generated a mortality risk score that was either higher or lower than what they expected. Physicians also indicated that 32 percent of test results would lead to a definite or possible change in treatment plan, with the net effect of shifting patients from more aggressive to more conservative treatment. These data strongly suggest that the Prolaris test can help physicians determine the aggressiveness of prostate cancer and tailor treatment plans for individual patients. A second large prospective clinical utility
study called PROCEDE 500 also is underway. An interim analysis of that study showed that physicians would change actual treatment selection in 65 percent of cases after they reviewed the results of the Prolaris test with their patients. Data from PROCEDE 500 will be presented at the ASCO Genitourinary Cancers Symposium in San Francisco on Jan. 30, 2014.
Prolaris CCP Score Stratifies Risk for Prostate Cancer Patients at Biopsy: Initial Commercial Results. [Crawford et al., Poster Session II: Dec. 6, 2013, 4:30 p.m. ET]
This study focused on the Prolaris test's accuracy in predicting the aggressiveness of prostate cancer based on analyses of biopsy samples. A total of 1,604 patient samples were included for analysis. The study found that Prolaris improved risk stratification for men with prostate cancer independent of the Gleason score and PSA level. Specifically, the results showed that 27.9 percent of men had a less aggressive cancer compared to the standard pathologic prediction and were assigned to a lower risk group, while 27.6 percent had a more aggressive cancer. More than 50 percent of men initially tested in the commercial assay were assigned to a different risk category than predicted by their standard pathologic features alone. These findings underscore the prognostic utility of Prolaris in a commercial setting.
Prognostic Utility of the Cell Cycle Progression Score Generated from Needle Biopsy in Men Treated with Prostatectomy. [Bishoff et al., Poster Session I: Dec. 5, 2013, 4:00 p.m. ET]
This study demonstrates the ability of the Prolaris test in predicting cancer progression, as measured by both biochemical recurrence and metastatic disease after radical prostatectomy. The study found that the Prolaris test was a strong predictor of biochemical recurrence and was the strongest predictor of metastatic disease. High risk patients had over a six-fold higher risk of developing metastases compared to low risk patients. These results indicated that the Prolaris test can be used at the time of disease diagnosis to better define patient prognosis and help select the appropriate clinical care.
Cell Cycle Progression Score Predicts Metastatic Progression of Clear Cell Renal Carcinoma After Resection. [Poster Session I: Dec. 5, 2013, 4:00 p.m. ET]
This study evaluated the prognostic value of a cell cycle progression test on patients with renal cell carcinoma. Twenty-six patients and 38 controls were evaluated. The analysis revealed that the spread of a cancer to the blood vessels and lymph nodes, tumor grade and cell cycle progression score were the only independent variables that significantly predicted progression to metastasis. A combined analysis of age, cell cycle progression, tumor size and the spread of a cancer to the blood vessels and lymph nodes revealed an area under the curve of 0.84 that decreased to 0.78 if the cell cycle progression score was excluded. These findings indicate that the cell cycle progression score predicts metastatic progression after resection of organ-confined, clear-cell renal cell carcinoma and appears to add prognostic information to standard clinical and pathologic variables. These findings
warrant further investigation.
Prolaris is a novel prognostic test developed by Myriad Genetics 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 multiple genes related to the progression of tumor cell division. Prolaris can identify low or intermediate-risk patients who may be candidates for surveillance as well as patients who may be potentially at higher risk and would benefit from closer monitoring or additional therapy. Prolaris has been proven to predict prostate cancer-specific disease progression in five published clinical trials.
For more information visit: www.prolaris.com and www.myriad.com/understanding-prostate-cancer/.
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: www.myriad.com.
Myriad, the Myriad logo 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 presentation of Prolaris clinical study data at the Society for Urologic Oncology 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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Source: Myriad Genetics, Inc.
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