EDP Biotech Forges ColoMarker Global Distribution Partnership

EDP Biotech has formed distribution agreements with more than 25 partners in Europe, Asia and South America, in anticipation of launching its early-stage colon cancer blood test this year, the Knoxville, Tenn., company announced Tuesday. The blood test, known as ColoMarker, received the CE Mark in 2014.

ColoMarker allows medical personnel to detect biomarker CA11-19, which displays a high correlation with early-stage colon cancer.  In a multicenter clinical trial, the test showed a sensitivity of nearly 100 percent for early-stage colon cancer during stages I and II and a 98 percent overall cancer detection rate, the devicemaker said.

EDP Biotech CEO Alan Jernigan said ColoMarker will yield higher patient compliance, reduce health care costs and ultimately save lives. He hopes for FDA submission later in the year.

A routine colonoscopy is the most useful way to detect colon cancer, but not enough people comply, EDP consultant Dr. Herbert Fritsche notes. He says a simple blood test is a desired alternative to fecal occult blood- and DNA-based assays currently in use.

Colon cancer, which has a five-year survival rate of almost 90 percent if detected early, stands projected to claim almost 50,000 lives in the U.S. this year. — Jason Scott