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Prolaris(R) Test Predicts Mortality Risk In Prostate Cancer Biopsy Study

SALT LAKE CITY, May 20, 2014 (GLOBE NEWSWIRE) -- 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). 
Prolaris Predicts 10-Year Death Rates from Prostate Cancer
Prolaris Test Score <0 0-1 1.1-2 >2
Death Rate (%) 7 15 36 59

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.

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