Diagnostic Test to Eliminate Unnecessary Prostate Biopsies

PCSC04 is a prospective study of 200 pre-prostate biopsy patients initiated in November 2006. The study was designed to test whether a biomarker diagnostic would be able to reduce the number of unnecessary biopsies when used sequentially with the prostate- specific antigen (PSA) test and best clinical care practices. The study is being performed by CMX Research Inc. (Canada), a Canadian Site Management Organization (SMO)

The company has completed examination of 130 of the 200 patients enrolled in the study. The data analyzed have shown that approximately 20% of the biopsies for the patients who did not have prostate cancer could have been avoided with the use of the test. In addition, the diagnostic identified 96% of the patients who were true positives for prostate cancer and were required to proceed with a biopsy for further diagnosis.

The PSA test is the current screening standard for prostate cancer. Approximately 70% of PSA tests performed in the United States result in false-positive diagnoses, requiring these patients to undergo unnecessary prostate biopsies. Many of these biopsies could be avoided with a more accurate diagnostic tool. The new biomarker test, which was developed by Miraculins (Winnipeg, Canada), will help reduce the number of men who undergo unnecessary biopsies will be welcomed by clinicians who are concerned about the poor performance of PSA alone.

"The initial results of our study are positive and significant,” stated Christopher J. Moreau, president and CEO of Miraculins Inc. The potential impact of our test on healthcare costs would be dramatic. Last year, in the United States alone, there were 750,000 biopsies performed that produced negative results. At a cost of approximately US$2,000 per biopsy, every 10% reduction in unnecessary biopsies equals an annual cost savings of $150 million.”

Prostate cancer is the most common cancer in Canadian men, affecting one in seven, and the most common non-skin cancer in the United States, affecting one in six men. It is often slow growing and can be managed successfully if detected early through diagnostic screening.


Related Links:
CMX Research
Miraculins