EDP Biotech currently has six (6) clinical research studies on-going in the EU to support its new and improved, 2nd Generation ColoMarker® test 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 middle of 2018.
In addition, EDP Biotech has completed and published a US clinical research study for its 1st Generation ColoMarker assay 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 1st Generation ColoMarker®. 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