Myriad Genetics has announced the launch of a 46-gene prognostic test which is supposed to be able to determine the risk of prostate cancer recurrence in patients who have undergone a radical prostatectomy.
According to the company’s media release , the test will be known as PROLARIS™. It is a molecular diagnostic assay that is based on cell growth and tumor biology and”provides rigorous, quantitative measures of the expression levels of multiple genes related to progression of the cell cycle.” The cost of the test will be $3,400, and it is going to be interesting to see how many insurers will be willing to cover that cost (as compared to regular post-surgical PSA tests).
In a somewhat less than ringing endorsement for this new assay, Dr. Peter Carroll of the University of San Francisco is quoted as stating that, “PROLARIS may offer very important information to the patient and his physician about the risk of his cancer recurring” [bold italic type added for emphasis].
The PROLARIS test is apparently capable of identifying patients at low risk of disease recurrence with 95 percent certainty. Of course what this really means is that there will continue to be a significant set of men who, after radical prostatectomy, can not have a high degree of confidence that their cancer has been effectively eliminated. However, Myriad Genetics has also stated that they are performing additional tests to validate the utility of PROLARIS.
In one such test, based on data from 365 prostate cancer patients, 98.5 percent of patients with a low (favorable) PROLARIS score survived their disease after 10 years, compared to just 57.6 percent of the patients with a high (unfavorable) score who had died of prostate cancer within 10 years.
Clinical and scientific data related to the use of PROLARIS is scheduled for presentation at the 2010 Genitourinary Cancers Symposium in San Francisco later this week. The abstract of the presentation by Swanson et al. (entitled “Cell cycle genes predict recurrence after radical prostatectomy”) will be made publicly available by the American Society of Clinical Oncology tomorrow (Wednesday, March 3, 2010) at 6:00 pm Eastern.