Mainz Biomed Moves Forward With Pivotal CRC Study After Feasibility Trial

Mainz Biomed

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(RTTNews) - Mainz Biomed NV (MYNZ), a molecular genetics diagnostic company, on Tuesday announced the launch of the eAArly DETECT 2 feasibility study to evaluate its next-generation colorectal cancer or CRC test.

The study will involve approximately 2,000 average-risk patients and aims to validate earlier results on detecting advanced adenomas or precancerous polyps and early-stage CRC.

The eAArly DETECT 2 study integrates mRNA biomarkers, an AI-driven algorithm, and a FIT test to enhance diagnostic sensitivity and specificity.

It will further assess how these biomarkers can identify advanced adenomas and early-stage CRC in a large population. Enrollment for the study is expected to complete in the second half of 2025, with topline results anticipated by the fourth quarter of 2025.

The biomarkers, acquired from Sherbrooke University in 2022, have shown the potential to detect curable adenomas and treatable early-stage CRC.

Based on the study results, Mainz Biomed plans to finalize protocols for its ReconAAsense pivotal study, set to begin in 2026.

This next-generation CRC test aims to transform colorectal cancer screening, offering an opportunity for early detection and potentially preventing cancer.

Currently, MYNZ is trading at $4.74 down by 1.67%.