MDxHealth is a multinational healthcare company that provides actionable epigenetic information to personalize the diagnosis and treatment of cancer. The increased adoption of our ConfirmMDx® for Prostate Cancer testing solution within the U.S. urology community has established MDxHealth as a market leader in the important and growing field of cancer epigenetics.
Epigenetics is an exciting area of molecular biology that identifies key changes in gene activity that do not involve changes to the underlying genetic code. Epigenetic "markers" tell genes to switch on or off, to speak loudly or whisper. It is through these epigenetic markers that environmental factors like diet, stress and prenatal nutrition can make an imprint on genes (DNA methylation) that are passed from one generation to the next. Certain of these DNA methylation imprints can turn a health cell into a cancer cell.
Our goal is to build on the success of ConfirmMDx for Prostate Cancer, leveraging our expertise in epigenetics, to establish MDxHealth as the molecular diagnostics leader in urological oncology. ConfirmMDx has been shown in published studies to distinguish patients who have a true-negative prostate biopsy from those who may have undetected cancer.
With approximately 1 million men receiving an inconclusive biopsy result each year in the U.S., we believe that our ConfirmMDx solution addresses a significant unmet medical need for timely, actionable information that can aid in the reduction of unnecessary repeat biopsies.
We believe that our proprietary, accurate and scalable epigenetic technologies provide MDxHealth with a key competitive advantage in the diagnosis, prognosis and management of cancer. In addition to our ongoing and planned studies to expand the clinical utility of ConfirmMDx for Prostate Cancer, our product pipeline includes tests for bladder, kidney and other urologic cancers. For other cancer types, we have engaged partners to commercialize our epigenetic technologies, as shown by the successful launches of Cologuard® for colon cancer by licensee Exact Sciences and PredictMDx® for Glioblastoma by licensee Laboratory Corporation of America (Labcorp).
We currently offer our laboratory solutions from our state-of-the-art, 13,444 sqft, College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and ISO 9001:2008 certified, molecular laboratory facility located at our U.S. headquarters in Irvine, California. Our European corporate headquarters is located in Herstal, Belgium and our NXTGNT (Epi)genomics research joint-venture with Ghent University is located in Ghent, Belgium.