Mainz Biomed Joins Forces with Trusted Health Advisors for U.S. Launch of Colorectal Cancer Diagnostic Tool

Mainz Biomed N.V., a pioneer in molecular genetics diagnostic solutions for early cancer detection, has announced its partnership with Trusted Health Advisors (THA) to support the market introduction of its next-generation early colorectal cancer diagnostic tool in the United States. The collaboration is spearheaded by Dr. Jay Wohlgemuth, ex-Chief Medical & Scientific Officer of Quest Diagnostics, and Dr. Ray Tabibiazar, an experienced industry executive.

Mainz Biomed is progressing towards the final regulatory planning phases for its ReconAAsense clinical trial. This trial aims for Premarket Approval (PMA) of its nucleic acid-based detection test for colorectal cancer screening. This initiative aligns with Mainz Biomed's strategy to distribute its products through partnerships with third-party laboratories, expanding the accessibility and efficiency of cancer screening diagnostics.

The company's CEO, Guido Baechler, emphasized the potential of the partnership with THA to streamline and enhance the commercial strategy in the U.S., aiming for a market introduction in 2026. Dr. Wohlgemuth remarked on the early detection capabilities of Mainz Biomed's test in identifying Advanced Adenomas, crucial for early intervention and successful treatment outcomes. Dr. Tabibiazar highlighted the test's ease of use and the innovative business model as critical factors in improving patient access and outcomes.

ReconAAsense, the pivotal FDA PMA clinical trial by Mainz Biomed, seeks to integrate novel gene expression biomarkers for colorectal cancer screening, aiming for highly accurate results. Preliminary studies have shown promising sensitivity and specificity levels in detecting colorectal cancer and Advanced Adenoma, positioning Mainz Biomed's test as a potential breakthrough in early cancer detection and prevention.