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EDP Biotech’s ColoMarker obtains CE mark approval

US-based EDP Biotech has received CE mark approval for its ColoMarker, which will be used to detect Colon Cancer.

The EDP ColoMarker test will allow clinicians in the early detection of colon cancer, and it only requires a small sample of blood.

EDP Biotech chairman Tom Boyd said: "Our product can now bear the CE Mark, which demonstrates that the ColoMarker test complies with the stringent requirements related to the quality, safety, and performance of in vitro diagnostic tests found in the applicable EU laws."

Initially, the company will introduce the product in the thirty member states of the European Economic Area (EEA).

EDP said that it has clinically tested ColoMarker in several US institutions with thousands of patients of both known and unknown stages of cancer, and results demonstrated sensitivity of 97% and a specificity of 86% for colon cancer and 48% detection of adenomatous polyps.

EDP Biotech scientific advisory board chairman Bergein Overholt said: "ColoMarker has the potential to literally change the way we practice medicine when it comes to the diagnosis and management of colon cancer."