Mainz Biomed Launches U.S. Study for Advanced Adenoma Detection

Mainz Biomed N.V. has commenced the eAArly DETECT 2 study in the U.S. to assess its next-generation colorectal cancer (CRC) test. This research includes 2,000 average-risk patients and aims to validate prior findings. The test integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test.

The test's focus is on detecting precancerous adenomas and early-stage CRC. Completion of patient enrollment is expected in the latter half of 2025, with results anticipated in Q4 2025. Based on results, the company aims to finalize the protocol for its U.S. pivotal study, ReconAAsense, set for 2026.

Mainz's novel gene expression biomarkers, acquired in 2022, target early CRC detection and prevention through identification of curable precancerous polyps. This advancement could significantly enhance early diagnosis and screening accuracy.