Following the success of its preclinical trials for the ColoMarker assay, EDP Biotech Corp. (Knoxville, TN, USA) has filed a patent on the biomarker, CA11-19, and all aspects of its use. Via an inexpensive blood test, ColoMarker will detect colon cancer in its earliest, most curable stages.

“American Cancer Society statistics show that when colon cancer is detected in its early stages, more than 90% of patients will survive. If not detected until the later stages, fewer than 10% will survive. ColoMarker detects colon cancer in these early, highly curable stages,” said Kevin Jones, Ph.D., chief scientific officer of EDP.

According to American Cancer Society (Atlanta, GA, USA) statistics, fewer than 20% of Americans over the age of 50 who should be screened for colon cancer actually are tested. With the use of ColoMarker, a simple and inexpensive blood test, the number of people being screened would likely increase considerably, leading to a decline in deaths due to colon cancer.

In preclinical trials, ColoMarker successfully detected the early stages (I, II, and III) of colon cancer. In tests of 2,370 blood samples, ColoMarker showed an accuracy rate of > 99% for detecting colon cancer in these early stages. “ColoMarker could lead to a radical shift in the way we detect colon cancer,” added Dr. Jones.

U.S. researchers who study colorectal cancer are closely monitoring emerging technologies such as ColoMarker. Their findings are encouraging; in December 2009, the American Cancer Society, the U.S. National Cancer Institute, the U.S. Centers for Disease Control and Prevention and the North American Association of Central Cancer Registries released an optimistic report about the expected decline in deaths from colon cancer due to anticipated improvements in early screening methods.

Dr. Jones stated, “The use of ColoMarker as a screening test could save tens of thousands of American lives every year and billions of dollars in healthcare costs.” EDP Biotech is now moving forward expeditiously to get ColoMarker through the U.S. Food and Drug Administration (FDA) clearance process.

EDP is a medical device company focused on the development and sale of immunodiagnostic tests for both humans and animals. EDP utilizes more than 30 years of research and development in identification and purification of proteins present in the early stages of biologic changes for production of in vitro diagnostic tests whose primary target is early detection products.

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