MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the
Diagnosis and treatment of cancer
Over the past three years, the widespread adoption of the ConfirmMDx® for Prostate Cancer testing solution within the US urology community has established the Company as a market leader in the important and growing field of cancer diagnostics. Now, with the acquisition of NovioGendix the Company is well positioned to enter a new and expanding market for non-invasive, liquid biopsy tests. Liquid biopsy, which represents $28 billion market opportunity in oncology, describes the testing of non-invasively derived specimen types, including biological fluids such as blood, urine, sputum and saliva, as compared to tissue collected by invasive biopsies. The urine-based SelectMDx™ for Prostate Cancer assay is the first in the Company’s pipeline of liquid biopsy tests, followed by the urinebased AssureMDx™ for Bladder Cancer test. The Company continues to build upon its position in (Epi)genetics, which 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 healthy cell into a cancer cell. Our goal is to build on the success of our lead product, leveraging our expertise in molecular diagnostics, to establish MDxHealth as the molecular diagnostics market leader in urological oncology. Our strategic roadmap to achieve this goal includes:
- increasing utilization of our lead product, ConfirmMDx for Prostate Cancer, in the US
- securing favorable reimbursement for our lead product from US commercial payors
- expanding the clinical utility and actionability of our current and future solutions
- leveraging our sales force by introducing new innovatice diagnostic products for urological cancers
- strategically offering our lead product internationally
Our ConfirmMDx solution has been shown in published studies to distinguish patients who have a true negative prostate biopsy from those who may have undetected cancer. More than 2,500 urologists, representing 25% of practicing urologists in the US, have ordered our proprietary ConfirmMDx for Prostate Cancer test on over 35,000 patients since its launch in mid-2012. With approximately 1 million US men receiving a negative biopsy result each year with potentially inconculsive results, we believe that our ConfirmMDx solution addresses a significant unmet medical need for timely, actionable information that can aid in the reduction unnecessary repeat biopsies. Assuming a 30% test adoption rate, we estimate the potential US market for ConfirmMDx in excess $1 billion and we estimate the potential global market opportunity to be greater than $2 billion.
Our non-invasive urine based SelectMDx for Prostate Cancer test, launched 1st November 2015 in the Benelux Union, identifies men at low risk for prostate cancer, helping to both reduce unnecessary prostate biopsy procedures with their concomitant complications and expense, while also helping to identify those men at increased risk of harbouring high-grade disease who may benefit most from early detection and treatment. Of the nearly 2 million prostate biopsies performed each year worldwide, less than a third find cancer. Most of these men could have avoided a painful and invasive prostate biopsy procedure, with its associated side effects and costs. Assuming a 30% test adoption rate, we estimate the potential EU and US market for SelectMDx opportunity to be greater than $1 billion. 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, 13,444 sqft, College of American Pathology (CAP)- accredited and Clinical Laboratory Improvement Amendments of 1988 (CLIA) and ISO 9001:2008 certified, molecular laboratory facility located at our US headquarters in Irvine, California and through our state-ofthe- art 1,735 sqft diagnostic facilities in Nijmegen The Netherlands . Our European corporate headquarters is located in Herstal, Belgium and our NXTGNT (Epi)genomics research joint-venture with the University of Gent is located in Ghent, Belgium.