EDP Biotech announces CE mark approval for ColoMarker an in vitro diagnostic aid in early detection of Colon Cancer

Oct. 3, 2014

EDP Biotech, a leading in vitro diagnostic innovator of life-saving, easy-to-use cancer diagnostic tests using ELISA technology, has announced CE Mark approval for ColoMarker, an aid in early detection of Colon Cancer. This is a critical step toward commercialization of this unique product which will initially be introduced in the thirty member states belonging to the European Economic Area (EEA).

The EDP ColoMarker test is a quick and easy tool for clinicians as an aid in early detection of colon cancer when it is most treatable, and only requires a small sample of blood. EDP expects that ColoMarker’s affordable cost, effectiveness, and the convenience of a whole blood test will significantly improve compliance compared to colonoscopy-based cancer screenings and existing fecal testing options.

ColoMarker has already been clinically tested in several U.S. institutions with thousands of patients of both known and unknown stages of cancer (stages I-IV). Test results show a sensitivity of 97% and a specificity of 86% for colon cancer and 48% detection of adenomatous polyps. This test provides clinicians with a tool to detect colon cancer at its earliest, most treatable stage. The ColoMarker provides patients an economical, convenient, and minimally invasive way to get tested for colon cancer without the complexities of stool based tests; thus bridging the gap between compliance and accuracy. EDP plans to initiate the process for FDA approval in the next three months. Learn more about the ColoMarker.

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