EDP Biotech Announces CE Mark Approval for ColoMarker an in Vitro Diagnostic Aid in Early Detection of Colon Cancer and Plans for Commercialization in Europe
KNOXVILLE, Tenn.–(BUSINESS WIRE)–09/30/2014
EDP Biotech Corporation, (“EDP,” or the “Company”), a global 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 (priced somewhere between IFOBT and FIT stool tests), effectiveness, and the convenience of a whole blood test will significantly improve compliance compared to colonoscopy-based cancer screenings and existing fecal testing options.
“We are excited to introduce our innovative, life-saving product to the European market,” said Tom Boyd, Chairman of EDP. “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.”
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. Dr. Herbert Fritsche, retired tenured Professor of Laboratory Medicine & Chief of Clinical Chemistry; MD Anderson Cancer Center and Consultant to EDP states that “a routine colonoscopy is the best way to detect colon cancer and high risk polyps, but many people are not compliant, and a low cost blood test will be a welcomed option to the current fecal blood and DNA based assays for a directed colonoscopy.”
Bergein F. Overholt, M.D., Chairman of EDP’s Scientific Advisory Board, developer of the flexible fiberoptic sigmoidoscope which led to the colonoscopy, and past President of the American Society of Gastrointestinal Endoscopy states that “ColoMarker® has the potential to literally change the way we practice medicine when it comes to the diagnosis and management of colon cancer.”
EDP’s 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. For more information about the EDP ColoMarker® test, please visit www.edpbiotech.com.
EDP is also announcing plans for an imminent product launch with already identified distribution partners. The Company plans to appoint distribution partners in European countries where the Company does not currently have representation. The European Economic Area (EEA) comprises the three member states of the European Free Trade Association (EFTA) (Iceland, Liechtenstein, and Norway), and the 27 member states of the European Union (EU), including Germany, France, Italy, Spain, and Portugal.
EDP plans to initiate the process for FDA approval in the next three months.
About Colon Cancer
Colon Cancer is the third biggest cancer killer in the US and is expected to cause 50,310 deaths in 2014. However, routine testing starting at age 50 can prevent many cases of colon cancer. If found and treated early, the 5-year survival rate is about 90%. Many people are not tested due to the high cost, inconvenience, and invasiveness of current options, only about 4 out of 10 are diagnosed at this early stage when treatment is most successful. If everyone aged 50 and older had regular screening tests, at least 60% of cancer deaths could be avoided. Screening tests can find polyps, so they can be removed before developing into cancer.
About EDP Biotech Corporation
EDP Biotech is dedicated to the development and commercialization of innovative cancer diagnostics, including simple, cost effective, and accurate technologies. EDP Biotech has research, license, or commercialization agreements with leading institutions, including GI associates and Covenant Health. For more information on EDP Biotech, visit www.edpbiotech.com.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this release that are not historical facts, including, without limitation, statements that relate to the Company’s expectations with regard to the future impact on the Company’s results from new products in development, may be deemed to be forward-looking statements. Words such as “expects”, “intends”, “plans”, “may”, “could”, “should”, “anticipates”, “likely”, “believes”, and words of similar import also identify forward-looking statements. These statements are subject to risks and uncertainties. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined, and assumptions of management. Readers are urged not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Except as may be required under applicable law, we assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
Jeff Hooper, 865-584-0550