The epigenetic assay, ConfirmMDx for Prostate Cancer, is designed for the diagnosis and subsequent treatment of prostate cancer (PCa) patients.

The test also helps urologists distinguish patients who have a true-negative biopsy from those at risk from occult cancer, and rule out prostate cancer-free men from undergoing unnecessary repeat biopsies.

The Epigenetic Field Effect study, conducted in histologically benign prostate biopsy core patients, has shown that GSTP1, APC and / orRASSF1 gene promoter methylation is more prevalent in histologically benign cores from PCa patients diagnosed with Gleason Score (GS) 7 PCa, as compared with low volume GS 6.

The company said the study confirmed previous findings in a larger cohort of subjects that the field effect biomarkers can be useful for detecting cancer alongside histologically negative biopsies, and may be indicative of occult aggressive PCa.

A second study demonstrated that epigenetic profiling is a significant predictor for PCa risk, especially to identify whether a patient should undergo a repeat biopsy following a negative initial biopsy.

An integrated risk management approach that combines the epigenetic assay with other risk factors, most notably histopathologic features of the cancer-negative initial biopsy, resulted in an improved prediction for the presence of PCa with sensitivity and negative predictive values of respectively 74% and 91%, according to the company.

MDxHealth clinical pathologist and medical director Dr Jesse Savala said, "With the advances being made in human epigenetics, we believe that DNA methylation-based tests hold the promise to improve the diagnosis and subsequent treatment of cancer patients."