MDxHealth SA Reports Positive Results for Prostate Cancer Diagnostic Test
Tuesday, 15 Nov 2011 03:29am EST
MDxHealth SA 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. The prospectively designed study, conducted at three prestigious United States urology centers (Johns Hopkins, Walter Reed Army Medical Center, and the Cleveland Clinic Foundation) evaluated 86 men with an initial histologically negative prostate biopsy and characteristics that deem them high-risk for having cancer. Blinded methylation testing was performed on paraffin embedded prostate biopsy tissue. The relative negative predictive value (NPV), the primary objective of the study, of the DNA methylation assay was found to be 96%. The authors recommend a larger validation study, and if similar results were achieved, the data suggest that about 30% of men suspected of having cancer could avoid repeat biopsies. MDxHealth is conducting such a validation trial using its Prostate ConfirmMDx assay.