Mainz Biomed to present results of ColoFuture study

Mainz Biomed will present the detailed results from its ColoFuture study at the 4th International Conference on Gastroenterology which occurs on October 16th – 18th in Paris, France. The ColoFuture study was a multi-center international clinical trial assessing the potential to integrate a portfolio of novel gene expression biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use screening test for colorectal cancer being commercialized across Europe and in select international territories. “The data generated from this study represents a potentially ground-breaking milestone for CRC detection and we are excited to share the details of our findings with the attending audience of international medical experts,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Multiple novel mRNA biomarkers were identified for possible integration into our pivotal FDA PMA clinical trial, and we look forward to comparing ColoFuture’s data outcome with results from our eAArly DETECT clinical study which remains on track to report in Q4 of this year.” The ColoFuture study was an international clinical trial assessing the performance of ColoAlert with the Company’s novel mRNA markers to determine sensitivity and specificity for colorectal adenocarcinoma and advanced precancerous lesions in the colon. It included 220 subjects aged 40-85 from participating centers in Germany, Norway and Denmark. The Company reported topline results from ColoFuture in September 2023, and key highlights included a sensitivity of 94% and specificity of 97% for colorectal cancer, along with a sensitivity of 81% for advanced adenomas. The eAArly DETECT study is the U.S. component of ColoFuture which is enrolling 250 subjects across 25 sites.