KNOXVILLE, TN - 2/26/2016 (PRESS RELEASE JET) -- EDP Biotech, a privately-held company providing in-vitro diagnostic test kits for the detection of early colorectal cancer, announces the first multi-center data for CA11-19 detection by ColoMarker – a simple blood test – in CA11-19: a tumor marker for the detection of colorectal cancer , appearing in the March issue of the journal Gastrointestinal Endoscopy. Accompanying the article is an on-line author’s video by Dr. Bergein Overholt, M.D. highlighting the potential benefit of CA11-19 in clinical practice. Clinical performance of ColoMarker was determined utilizing a cohort of 522 consecutively collected serum samples that were obtained under a multi-center IRB protocol. Blood samples were blinded and clinical status was confirmed with colonoscopy prior to testing. Additionally, reproducibility of ColoMarker was evaluated using blinded, duplicate samples run in two U.S. locations and then analyzed.
Data from this multi-center research study demonstrated ColoMarker's 98% sensitivity with 84% specificity in detecting all colorectal cancer. Moreover, the test had 40% sensitivity to pre-cancerous polyps. “If these results are validated by other institutions, approved by the FDA and commercialized, this test will strongly influence the practice of gastroenterology and the management of colorectal cancer patients,” explained 1st author Dr. Bergein Overholt.
EDP Biotech CEO, Eric Mayer stated, “March is Colorectal Cancer Awareness month and highlights the importance of testing for early detection and successful treatment. Colon cancer is the 3rd leading cause of cancer deaths globally, most of which could be prevented by early testing. The lack of patient-friendly testing for CRC is a major contributor to the low compliance rates, currently estimated at less than 60%. We believe that a simple, effective blood test like ColoMarker (CA11-19) will be a valuable diagnostic tool for identification of early-stage disease to win the fight against colorectal cancer.”
About EDP Biotech
Based in Knoxville, Tennessee, EDP Biotech is dedicated to the development and commercialization of innovative cancer diagnostics, including simple, cost-effective, and accurate ELISA-based colon cancer technology. For more information on EDP Biotech, EDPbiotech.com. ColoMarker received CE Mark approval in late 2014 and is not currently approved for clinical use in the United States.
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