Positive data from MDxHealth's prostate cancer test study

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized cancer treatment, today announced data showing that a prototype of its Prostate ConfirmMDx™ test can help urologists distinguish patients who have a true negative biopsy from those who may have occult cancer undetected by prostate biopsy and histopathological review. If this early data is validated in a larger study, the results suggest that 30% of men suspicious for cancer after an initial negative biopsy could be spared a repeat biopsy. Prostate ConfirmMDx detects epigenetic changes in specific prostate cancer related genes, helping indicate the likely presence of cancer.

Data from the study have been published in advance online in the British Journal of Urology International (BJUI, Nov 2011), one of the leading urology publications. The authors, led by Alan Partin, MD, PhD, Chief of Urology at Johns Hopkins Medical Institution, note that this study is the first prospective trial in a defined clinical cohort with rigorous inclusion criteria to evaluate the potential utility of DNA methylation markers to predict outcome on repeat biopsy.

"Large numbers of men are subjected to repeat biopsies following an initial negative result because of persistently elevated PSA and other high-risk factors. However, cancer is found in only a minority of these men. Urologists need improved methods to help identify those men who may forego these invasive procedures," noted Joseph Bigley, Vice President of Clinical Affairs at MDxHealth. "The results from this study suggest that testing for DNA methylation changes could reduce the number of unnecessary repeat biopsies on otherwise healthy, cancer-free men."