Myriad Genetics, Inc., presented data from a clinical validation study of its Prolaris prostate cancer assay at the just-completed 2014 American Urological Association (AUA) Annual Meeting. Prolaris is a molecular diagnostic test that predicts cancer-specific death and metastases in men who were diagnosed by needle biopsy. A key finding of the validation study 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.
The study’s goal was to validate the Prolaris test score in 761 conservatively managed prostate cancer patients diagnosed by 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. 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.
In a second study presented at the AUA meeting, 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 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. Learn more about the Prolaris test.
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