MDxHealth's Prostate ConfirmMDx test has been found to help urologists to distinguish between true negative biopsies and occult prostate cancers undetected by biopsy and histopathological review.
The assay identifies epigenetic changes in prostate cancer-related genes to indicate the likely presence of cancer.
The prospective study evaluated 86 men with an initial histologically negative prostate biopsy and found the relative negative predictive value to be 96%.
The company is currently conducting a validation trial using the assay.
MDxHealth CEO Jan Groen said that additional clinical validation studies for an improved version of the assay under way, and the company looked forward to launching the test for urologists through commercial its CLIA laboratory in the first half of 2012.