EDP Biotech currently has six (6) clinical research studies on-going in the EU to support ColoMarker® ELISA CE Mark and upcoming launch in Europe. Hospital and Clinical Laboratory collection sites in several countries throughout the EU aim to enroll 1,200 individuals by the end of 2017.
In addition, EDP Biotech has completed and published a US clinical research study in the Journal of Gastrointestinal Endoscopy. This research study was conducted under approved IRBs in the United States between 2010-2014. ColoMarker is not cleared for clinical use in the U.S.A.
The original Western IRB was granted 11/23/2010 for “Clinical Evaluation of CA11-19™ and Patient Clinical Status Confirmed by Colonoscopy”, Principal Investigator Dr. Bergein Overholt at GI Associates. All normal, polyps, benign GI diseases and carcinomas identified by colonoscopy were also included in the study.
A second IRB was with Covent Health granted 01/17/2012 for “Clinical Evaluation of CA11-19 Using patients Untreated Confirmed Colo-rectal carcinoma,” Principal Investigator Dr. Bergein Overholt and Dr. S. Spence McCachren(co-PI). EDP Biotech, Study Sponsor, evaluated the clinical sensitivity and specificity of the ColoMarker® ELISA immunoassay using EDP’s proprietary monoclonal and polyclonal antibodies to CA11-19™ with sera from both IRB studies. Results summaries of the published data can be found in Tables 1 and 2. Full text GIE article can be found here.
Note: All patients’ clinical status are Colonoscopy Confirmed