Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that a study published in Lancet Oncology shows the Company's 46-gene PROLARIS™ molecular diagnostic test significantly predicts prostate cancer outcome. The study demonstrated that a patient's cell cycle progression (CCP) score is a strong indicator of the risk of disease recurrence and death in patients diagnosed with prostate cancer and may play an essential role in determining the appropriate treatment for patients with prostate cancer. The study will appear in an article, entitled "Prognostic value of an RNA expression signature derived from cell cycle proliferation genes in patients with prostate cancer: a retrospective study."
"These findings have important implications," stated Jerry Lanchbury Ph.D., Chief Scientific Officer of Myriad Genetics Inc. "We believe the study provides very strong evidence that measuring the expression level for this family of genes is central to understanding the aggressiveness of prostate cancer and therefore the appropriate course of treatment."
The study presented CCP scores on 703 prostate cancer patients; 366 American men who had undergone radical prostatectomy and 337 men in the U.K. with clinically localized prostate cancer diagnosed by a transurethral resection (TURP). The study demonstrated the CCP score was a significant predictor of disease outcome for both population sets (p = 5.6 x 10-9 and p = 6.1 x 10-22, respectively).
Moreover, in the TURP patients, the CCP score was the most important variable for predicting death from prostate cancer (p = 8.2 x 10-11) with both PSA and Gleason score contributing to a lesser extent. In the cohort of patients who had undergone radical prostatectomy the CCP score and pre-operative PSA level were the most significant variables in predicting the recurrence of prostate cancer.
Myriad believes the market need for the PROLARIS™ product stems from the limited ability of current markers to accurately predict prostate cancer aggressiveness. 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, 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, which incorporates the CCP score, was developed to meet this significant need to improve the physician's ability to predict disease outcome and to thereby optimize treatment.
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