Mainz Biomed Launches eAArly DETECT 2 Clinical Study

Mainz Biomed N.V. has commenced the eAArly DETECT 2 clinical study by enrolling its first patient. This study targets over 2,000 average-risk individuals to validate its advanced precancerous lesions (APL) detection results. Utilizing proprietary mRNA biomarkers, an AI-driven algorithm, and a FIT test, it aims to enhance colorectal cancer (CRC) screening and prevention.

Completion of patient enrollment is anticipated in the latter half of 2025, with top-line results expected by the year's end. Following the study, Mainz Biomed plans to refine protocols for a pivotal U.S. study, ReconAAsense, scheduled for 2026.

The study aims to improve diagnostic accuracy in detecting early-stage CRC and APLs, thus advancing global cancer mortality reduction. This effort follows the acquisition of key gene expression biomarkers in 2022, specifically for identifying treatable precancerous conditions.