MDxHealth Announces Publication of Positive Data from a Blinded Multicenter Clinical Study Demonstrating the Utility of ConfirmMDxTM for Prostate Cancer to Address False-negative Biopsies

Results of the Study Published in the Journal of Urology

IRVINE, CA, and LIEGE, BELGIUM - February 11, 2013 - MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostic company that develops and commercializes epigenetic tests to support the diagnosis and treatment of cancer patients, today announced the publication of results from a large clinical study on its epigenetic ConfirmMDx^TM for Prostate Cancer test in the March 2013 issue of Journal of Urology. The results demonstrate the utility of the ConfirmMDx test as a powerful tool to address well-documented concerns over false-negative biopsy results.

The blinded, multicenter study named MATLOC (Methylation Analysis To Locate Occult Cancer), was conducted at University of Edinburgh Urological Cancer Group in the UK, the University Hospital of Liège, Belgium and the Institut de Génétique et Pathologie in Gosselies, Belgium.  The investigators compared the performance of the ConfirmMDx assay to the current standard of care for men with high-risk clinical factors for prostate cancer, but negative biopsy results.  Archived tissue samples from previous negative biopsies of 483 men at high risk were tested with the ConfirmMDx assay.  The ConfirmMDx test results were then compared to the cancer detection rate in the repeat biopsies conducted on the same patients within 30 months.

In a multivariate model, correcting for age, PSA, DRE and histopathological characteristics of the first biopsy, the ConfirmMDx assay proved to be the most significant, independent predictor of patient outcome with an odds ratio of 3.17 (95% confidence interval: 1.81-5.53) along with atypical cells in the first biopsy (3.17 odds ratio; 95% confidence interval: 1.31-7.70).  The investigators report that ConfirmMDx accurately identified 64% of the prostate cancer-free men who could safely avoid a repeat biopsy with a negative predictive value (NPV) of 90%. Importantly, the test also correctly identified 68% of men who were harboring undetected prostate cancer at the time of their previous histopathologically negative biopsy, many presenting with clinically significant cancer upon repeat biopsy who would merit aggressive treatment.

"Concerns over false-negative biopsy results are universally shared by all urologists, especially when considering that the current standard of care involving 12 needle biopsy tissue cores effectively samples less than 1% of a man's prostate.  The MATLOC study demonstrates that the ConfirmMDx for Prostate Cancer test can provide urologists with a critical tool to better stratify patients at low risk of prostate cancer from those men at high risk and to make more informed decisions on the need for repeat biopsy," said Eric Wallen, MD, a practicing urologist at the Division of Urology and Professor of Surgery at the University of North Carolina at Chapel Hill, who serves as a consultant in the role of Chief Medical Officer for MDxHealth.  "As the cost of cancer continues to rise and challenge healthcare budgets throughout the world, well-validated biomarkers like those used in the ConfirmMDx test will play an increasingly important role in improving patient care while reducing health care costs."