"These findings are of great potential clinical significance," stated Jerry Lanchbury Ph.D., Chief Scientific Officer of Myriad Genetics, Inc. "We believe that this latest study provides very strong evidence that the PROLARIS test has an important role to play in defining the aggressiveness of a given prostate cancer, at the point of biopsy, and therefore provides essential guidance to physicians and their patients on the appropriate course of treatment."
Researchers analyzed the PROLARIS CCP scores for 352 men whose clinically localized prostate cancer was diagnosed by needle biopsy. They compared the predictive nature of the PROLARIS CCP score in biopsies to accepted clinical variables including Gleason score, baseline PSA, age, clinical stage and the extent of the disease. The study determined that the PROLARIS CCP score was the strongest predictor of cancer death outcome (p = 1.4 X 10-10) and more significant than either Gleason score or PSA.
Myriad believes the market need for the PROLARIS product stems from the limited ability of current markers to accurately predict prostate cancer aggressiveness at time of biopsy. Many men diagnosed with prostate cancer have indolent disease that can be safely monitored with active surveillance, whereas some patients have aggressive cancer and need immediate treatment. The challenge facing all men diagnosed with prostate cancer is to decide whether to have aggressive therapy such as radiation or radical prostatectomy which has potentially significant complications such as, incontinence and impotence or to monitor the disease through active surveillance. Overtreatment of prostate cancer and its attendant complications is widely recognized as an important public health issue and places an unnecessary financial burden on the health care system. The PROLARIS product was developed to meet this significant need to improve the physician’s ability to predict disease outcome and to thereby optimize treatment.