EDP Biotech, the US-based developer of a blood test to detect the early stages of colon cancer called ColoMarker™, today announced its plans to commercialize the product and bring the new technology to market. Unlike other diagnostic tests currently in development, the ColoMarker test detects a level of CA11-19 antigen, a specific protein molecule found in the bloodstream. While every human being produces this protein, elevated levels in the bloodstream suggest the presence of colon cancer.
Recent third party validation of ColoMarker™, demonstrating test accuracy of 95 percent, has positioned EDP Biotech to pursue market launch in the near future. To EDP’s knowledge, no other routine sandwich ELISA technology identifies 95 percent of early stage colorectal cancer in blood.
EDP Biotech has partnered with Corgenix Medical Corporation to manufacture ColoMarker™. Corgenix is a world leader in the development and manufacturing of specialized diagnostic kits for more than 20 years. EDP is also aggressively pursuing CE Mark and fully anticipates approval and subsequent commercialization in Europe by the end of this year, followed by a strategic path towards FDA approval.
“We developed ColoMarker because of the critical need to detect cancer at its earliest stages,” says Tom Boyd, CEO of EDP Biotech. “This validation confirms that our technology has strong potential to save thousands of lives each year through early stage detection, and it’s our goal to make it available to diagnostic oncology labs and accessible to medical professionals throughout the world.” ColoMarker™ has proven to be effective in identifying elevated levels of a biomarker in the bloodstream in 95 percent of early stage colorectal cancers, when the disease is most treatable and survival rates are highest. To date, physicians have relied primarily on colonoscopies and fecal occult blood testing (FOBT) to identify potential cases of early stage colon cancer.
A critical part of EDP Biotech’s research and development of the ColoMarker technology has been the involvement and consultation of some of the world’s most recognized experts in this field: Dr. Gene Overholt – inventor of the scope for colonoscopies and recognized worldwide as the “father of the colonoscopy” Dr. Herbert Fritsche – one of the world’s leading experts on cancer biomarkers and former Chief of Clinical Chemistry at MD Anderson Cancer Center Dr. John Costanzi – internationally-known and considered a leading expert in the treatment of cancer Recently Dr. Donald Wheeler – author, professor, statistician and renowned quality control expert – also joined EDP Biotech’s scientific advisory board as the company approaches commercialization.
For more information, visit www.edpbiotech.com.