On May 12, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported new data demonstrating the utility of the Prolaris test to accurately predict the 10-year risk of metastases in men treated for prostate cancer (Press release, Myriad Genetics, MAY 12, 2017, View Source [SID1234519100]). The data are being presented tomorrow at the American Urological Association (AUA) 2017 Annual Meeting in Boston, Mass.

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This study was conducted in collaboration with Stephen Bardot, M.D., and colleagues at Ochsner Clinic in New Orleans, Louisiana. A total of 767 men with localized prostate cancer were evaluated using the Prolaris test plus CAPRA (i.e., clinical features) to predict the risk of metastatic disease up to 10 years following diagnosis. Approximately 40 percent of the patients in the study were African Americans (AA). Among all 767 patients 39 men, or 5.1 percent, developed metastases and among the 646 men who received definitive therapy (e.g., surgery, radiation, radiation and hormones) 28 men, or 4.3 percent, developed metastatic disease.

The results showed that the Prolaris test was a significant predictor of metastatic disease with a nearly 3-fold increased risk for each one-unit increase on the Prolaris test score (Hazard Ratio per unit score = 2.76; P = 2.8×10-11). Importantly, there was no difference in predictive performance between races (p=0.20) or treatment groups (p=0.09). When combined with CAPRA the Prolaris test was highly predictive of metastatic disease (HR for combined clinical risk (CCR) = 3.86; p= 2.8×10-23). Contrary to expectations, this large study found no evidence that AA men have more aggressive prostate cancer than non-AA men after accounting for all molecular and clinical information.

"Our study confirmed that the Prolaris test significantly predicts which men are likely to develop metastatic disease, regardless of race, risk group or treatment approach," said Dr. Bardot. "This study also included a large group of AA men which have historically been underrepresented in clinical outcomes studies. This study demonstrated that Prolaris provided more accurate precision in providing prognosis in African American and non-African Americans equally."

The findings from the current study are consistent with the findings of an earlier study that demonstrated the ability of the Prolaris test in predicting cancer progression, as measured by both biochemical recurrence and metastatic disease, after radical prostatectomy. That prior study found that patients with a high Prolaris test score had a six-fold higher risk of developing metastases compared to low risk patients.

Based on the strength of the data from these two outcomes studies, Myriad has added risk of metastases to the Prolaris test report for clinicians, making Prolaris the first and only genetic test to provide this endpoint as validated by two outcomes studies.

"Myriad Genetics is committed to innovation and being the leader in genetic testing for men diagnosed with prostate cancer," said Michael Brawer, M.D., senior vice president of Medical Affairs, Myriad Genetic Laboratories. "We have multiple outcome studies that show the ability of Prolaris to predict the 10-year risk of prostate cancer specific mortality, and we now have two studies that predict the risk that treatment will fail and men will end up with metastatic disease. We are excited to provide all of this relevant information in a single test report for clinicians."

Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #AUA17. Details of the presentation at AUA follow.

Featured Presentation
Title: Evaluating the Prognostic Utility of the CCP Score for Predicting Prostate Cancer Aggressiveness in African American Men
Presenter: Steven Bardot, M.D., Ochsner Medical Center
Date: Saturday, May 13, 2017: 7:00-9:00 a.m. ET.
Location: Moderated Poster MP28-19; Room 253AB.

About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in patients with prostate cancer. 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-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.