MDxHealth announces availability of ConfirmMDx for Prostate Cancer test

MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced it has presented data demonstrating that its epigenetic ConfirmMDx™ for Prostate Cancer test can aid urologists in identifying patients who may avoid a repeat prostate biopsy.

In men suspected to have prostate cancer, the potential for false-negative biopsy results is well documented in the literature. Approximately twenty-five percent of men receiving a negative histopathology result, the gold standard for diagnosis, could be harboring occult cancer. Fear over this issue leads to additional physician visits, screening, and repeat biopsies, often on prostate-cancer-free men. MDxHealth's ConfirmMDx test assesses the DNA methylation status of genes associated with prostate cancer. The test will help urologists differentiate patients with a true-negative biopsy from those who may have cancer undetected by prostate biopsy and histopathological review.

The data from the MATLOC (Methylation Analysis To Locate Occult Cancer) study presented during the Late Breaking Science Forum yesterday at the American Urology Association (AUA) Annual meeting in Atlanta, USA, revealed that the ConfirmMDx for Prostate Cancer test is a powerful tool to aid urologists in addressing false-negative biopsy concerns.

"With a high negative predictive value, exceeding that of standard microscopic histopathology review, the MATLOC study results demonstrate that the ConfirmMDx for Prostate Cancer test can help urologists confirm true-negative biopsy results, providing peace-of-mind and reducing unnecessary repeat biopsies," explained principle investigator Dr. Grant Stewart from the Edinburgh Urological Cancer Group at the University of Edinburgh, who presented the data. "The test will also help urologists identify high-risk men who may have occult cancer, enabling more effective triage of these patients with a repeat biopsy and treatment as required."

"These data confirm the high negative predictive value (NPV) and clinical utility of the ConfirmMDx for Prostate Cancer genes and DNA methylation technology previously reported in published studies. We believe the test fulfills an unmet medical need, complementing the current standard of care, and holds the potential to reduce unnecessary invasive procedures and the associated healthcare expenditures. Prostate biopsies pose significant risk of trauma and infection, at times requiring hospitalization. As a consequence, approximately one-third of men refuse to endure a repeat biopsy despite fear of a false-negative result, leaving these men at risk for disease progression. ConfirmMDx, a non-invasive assay performed on the residual prostate tissues from the previous negative biopsy, provides critical insights beyond histopathology to enable more informed patient management decisions," said Dr. Jan Groen, CEO of MDxHealth. "We are pleased to announce that ConfirmMDx for Prostate Cancer is now available to urologists directly through MDxHealth's state-of-the-art CLIA laboratory, and via our co-marketing partner PLUS Diagnostics."