SALT LAKE CITY, May 2, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today highlighted new clinical data on the PROLARIS 46-gene cell cycle progression (CCP) signature in patients with prostate cancer that will be presented at this year's American Urological Association (AUA) in San Diego.
"We have realized for some time that current clinical-pathologic features, while informative, are still inadequate in determining prostate cancer aggressiveness for an individual," said Michael Brawer, vice president of Medical Affairs at Myriad. "Every corner of the healthcare system including providers, payors, patients and health policy experts are asking for a test that can better determine prostate cancer aggressiveness and give more precise guidance of management options."
The clinical studies being presented at AUA focus on PROLARIS test results in patients who underwent radical prostatectomy or who were treated with external beam radiation therapy. In both of these prospectively-designed studies, the PROLARIS signature consistently demonstrated additional prognostic utility beyond what is available from standard clinical parameters such as Gleason score, prostate specific antigen (PSA) level and clinical stage.
"The PROLARIS signature is the dominant variable at diagnosis in predicting risk of prostate cancer progression, as determined by the gold standard oncologic endpoints such as biochemical recurrence, metastasis and prostate cancer death," said Brawer. "The PROLARIS score can provide personalized risk of cancer progression above that afforded by the Gleason score, clinical stage and PSA level. This information can help clinicians identify patients who are good candidates for conservative management and patients for whom monotherapy with surgery or radiation therapy may be inadequate."
These findings complement clinical data previously published in the peer-reviewed scientific literature. Myriad's PROLARIS test is the only commercial product that predicts prostate cancer death and has been evaluated in nine clinical studies with more than 3,000 patients. PROLARIS also is the only product that can be used in multiple sample types giving it applicability in both pre-treatment biopsy specimens and radical prostatectomy samples.
Below is a summary of the key data being presented at the 2013 American Urological Association annual meeting.
POSTER #985: Value of Cell Cycle Progression (CCP) Score to Predict Biochemical Recurrence (BCR) and Definitive Post-Surgical Pathology
Poster Presentation, Monday, May 6, 2013
Results from this prospectively-designed clinical study show that in patients who underwent radical prostatectomy, PROLARIS (CCP) score correlated significantly with organ confined, local invasive and systemic tumor growth, and these correlations remained after adjusting for Gleason score, PSA level and clinical stage. The PROLARIS score significantly represents real clinically and biologically relevant tumor features qualifying it as a promising biomarker for active surveillance in the post-surgical decision making processes as well as pre-surgical decision making processes as demonstrated in earlier clinical studies.
Key findings from this study demonstrate that the PROLARIS test was:
- A highly significant predictor of biochemical recurrence;
- Identified as a significant factor in predicting pathologic stage T3 cancer; and
- The best predictor for biochemical recurrence in low risk patients, whereas Gleason score was not significant.
POSTER #2242: Prognostic Utility of Cell Cycle Progression Score in Men with Prostate Cancer After Primary External Beam Radiation Therapy
Poster Presentation, Wednesday, May 8, 2013
Results from this prospectively-designed clinical study show that in patients who underwent external beam radiation therapy, the PROLARIS (CCP) score was significantly associated with survival outcome after radiation therapy and provided prognostic information beyond what was available from clinical parameters including Gleason score, PSA level and clinical stage. The PROLARIS score could be used to select high-risk men undergoing radiation treatment who may need combination therapy for their clinically localized prostate cancer.
Key findings from the study include:
- 57 percent of study subjects from the Durham VA Medical Center were African Americans;
- The PROLARIS score was a significant prognostic variable (the hazard ratio for biochemical recurrence was 2.55);
- The PROLARIS test provides prognostic information that is not provided by standard clinical parameters; and
- The PROLARIS score was significantly associated with prostate cancer specific mortality.
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 the leading causes of cancer death. Approximately 240,000 cases of prostate cancer are diagnosed and more than 28,000 men die from the cancer annually in the United States.
Optimal management of clinically localized prostate cancer presents a unique challenge to physicians and patients, because it is a highly variable and often slow growing, nonaggressive cancer. PROLARIS was developed to aid physicians in predicting disease aggressiveness in conjunction with clinical parameters such as Gleason score and PSA. PROLARIS measures the expression level of genes involved with tumor proliferation to predict disease outcome. PROLARIS provides unique additional information about a patient's prognosis and may be used with other clinical factors in helping the healthcare provider make treatment recommendations. For more information visit: 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 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. 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.
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 PROLARIS 46-gene cell cycle progression (CCP) signature predicting disease recurrence and mortality in patients with prostate cancer; the PROLARIS signature being the dominant variable at diagnosis in predicting risk of prostate cancer progression, as determined by meaningful endpoints such as biochemical recurrence, metastasis and prostate cancer death; the ability of the PROLARIS signature to provide personalized risk of cancer progression above that afforded by the Gleason score, clinical stage and PSA level; the PROLARIS score significantly representing real clinically and biologically relevant tumor features qualifying it as a promising biomarker for active surveillance in the post-surgical decision making processes as well as pre-surgical decision making processes; the use of the PROLARIS score to select high-risk men undergoing radiation treatment who may need combination therapy for their clinically localized prostate cancer; 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.