MDxHealth, Inc. To Participate In Prospective 4M Clinical Study Evaluating Synergy Of MRI And SelectMDx For Prostate Cancer

IRVINE, CA, and HERSTAL, BELGIUM, October 19, 2015 - MDxHealth SA (Euronext: MDXH), has entered into an agreement with Radboud University Medical Center in Nijmegen, The Netherlands, for the inclusion of the SelectMDx(TM) for Prostate Cancer test into the 4M prospective clinical study. The study is designed to evaluate the effectiveness of emerging technologies, including MRI and SelectMDx, for the improved selection of patients for prostate biopsy.

This prospective 4M clinical study on 600 subjects is designed to evaluate the effectiveness of emerging technologies for the improved selection of patients for prostate biopsy. MRI-guided biopsies have been reported to enable the identification potential prostate cancer lesions, allowing for targeted prostate biopsies, and improved accuracy of prostate cancer detection. SelectMDx, a non-invasive, urine-based “liquid biopsy” test, has been shown to improve patient risk stratification and can help reduce the number of unnecessary prostate biopsies. The study will evaluate the combination of SelectMDx and MRI procedures to establish more effective pathways for prostate cancer detection while minimizing the cost and morbidity associated with prostate biopsies.

Under the current standard of care, age, digital rectal examination (DRE) and Prostate Specific Antigen (PSA) are some of the common risk factors used to determine a man’s risk for prostate cancer and the need for a biopsy. The imprecision of these clinical measurements leads to a high rate of unnecessary prostate biopsies that are invasive and can lead to complications, while leaving some patients undiagnosed and at risk for disease progression.

“Given the recent controversy over PSA screening, and concerns about over diagnosis and treatment of prostate cancer patients, there is a well-defined need for better tools to diagnose and manage prostate cancer patients,” stated Prof. J.O. Barentsz MD PhD, principal investigator of the 4M study, at Radboud University Medical Center, Nijmegen, The Netherlands “We are eager to investigate the potential synergies of the SelectMDx test in combination with MRI. We want to know if the SelectMDx test can enhance patient selection for MRI-guided prostate biopsies, thereby optimizing resources, decreasing healthcare costs and improving patient outcomes.”