Intermountain Healthcare and Myriad Genetics will perform research and validation studies on molecular diagnostics being developed by Myriad. The first project under this collaboration, PRO 008, is designed to further expand the utility of the Prolaris test by analyzing biopsy samples of 200 patients diagnosed with prostate cancer.
This study will assess the ability of Prolaris to predict which men are at a heightened risk of biochemical recurrence and therefore should be given more aggressive therapy for their disease. Myriad has similar studies already under way in multiple centers in the U.S. and Europe.
Prolaris was developed to aid physicians in predicting disease aggressiveness in conjunction with clinical parameters such as Gleason score and PSA. The test measures the expression level of genes involved with cell cycle progression to predict disease outcome.
The signature has been evaluated in four retrospective clinical studies: a study of 366 patients predicted biochemical recurrence in those who had undergone radical prostatectomy; a study of 413 patients predicted biochemical recurrence in patients who had undergone radical prostatectomy; a study of 337 patients predicted 10-year mortality risk in patients with clinically localized prostate cancer diagnosed by transurethral resection and managed conservatively; and a study of 352 patients predicted 10-year mortality risk in patients with clinically localized prostate cancer diagnosed by needle biopsy and managed conservatively. Prolaris was a statistically significant predictor of clinical outcomes in all four studies, according to Myriad.