Molecular diagnostic company MDxHealth has reported results from two studies of its DNA methylation-based assay, designed for the diagnosis and subsequent treatment of prostate cancer (PCa) patients.
The epigenetic assay, ConfirmMDx for Prostate Cancer, 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 study also reasserts previous findings in a larger cohort of subjects that 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 the additional clinical studies add to the company’s extensive body of peer-reviewed evidence, clearly demonstrating the ability of ConfirmMDx for Prostate Cancer test to provide valuable diagnostic information to support urologists in better patient management.
"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," Savala said.
The company said it had presented the study results at the ASCO Genitourinary Cancers Symposium 2013, held at Orlando, Florida, US from 14 – 16 February 2013.