DURHAM, N.C. & LIEGE, Belgium--(BUSINESS WIRE)--MDxHealth SA (NYSE Euronext: MDXH), a leading molecular diagnostics company in the field of personalized medicine, announced today that its licensing partner Exact Sciences Corp. (Nasdaq: EXAS) has initiated a large pivotal trial for Cologuard™, its non-invasive, stool-based DNA colon cancer screening test. Exact confirmed that it is using an MDxHealth methylation biomarker together with MDxHealth’s methylation specific PCR (MSP) platform in Cologuard.
Exact’s multi-center DeeP-C study (Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer) will generate data to support its planned PMA submission to the U.S. Food and Drug Administration (FDA) in 2012. The company began enrolling patients in the study on June 30, 2011. It is planning to qualify approximately 60 sites in the United States and Canada for the study. Those sites are expected to enroll more than 10,000 patients between the ages of 50 and 84 who are at average risk for colorectal cancer.
“We are delighted with Exact Sciences’ progress and the start of the company’s important pivotal trial of its advanced screening test for colorectal cancer,” said Dr. Jan Groen, CEO of MDxHealth. “Based on a market penetration of 30% Exact is targeting a market opportunity of more than $1 billion in annual sales in the US alone. Once the test is commercialized, MDxHealth stands to receive royalties on net sales of Cologuard.”
About MDxHealth
MDxHealth is a leading molecular diagnostics
company that develops and commercializes oncology-based molecular
diagnostic testing and companion diagnostics for personalized medicine.
The company’s numerous cancer tests are based on proprietary gene
methylation technology and assist physicians with the diagnosis of
cancer, prognosis of recurrence risk, and prediction of response to a
specific therapy. MDxHealth collaborates with leading cancer research
center such as Johns Hopkins University, Duke University, Lovelace
Respiratory Research Institute, Eastern Virginia Medical School,
Cleveland Clinic, Memorial Sloan Kettering, and major European academic
medical centers. The company has a number of commercial and
collaborative partnerships with LabCorp, Merck & Co./Schering Plough,
GlaxoSmithKline Biologicals, Roche, Merck KGaA, Qiagen, Pfizer and other
industry leaders.
More information can be found on the Company website: www.mdxhealth.com or on twitter at the following address: www.twitter.com/mdxhealth.
This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the Company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.