Mainz Biomed reports topline results from pooled study of mRNA biomarkers

Mainz Biomed announced topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed’s ColoFuture and eAArly DETECT clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression biomarkers into a next generation version of the Company’s colorectal cancer screening tool. The topline results confirm the positive efficacy results previously reported with a sensitivity for colorectal cancer of 92% with a specificity of 90% and a sensitivity for advanced adenoma of 82%, which is best-in-class and compare favorably to existing commercial products. The pooled results include 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe. The two cohorts included patients that provided a stool sample before undergoing a colonoscopy to either screen for CRC. to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT. The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.