Mainz Biomed’s Pivotal FDA PMA clinical trial (ReconAAsense) evaluating gold standard self-administered colorectal cancer screening test
Mainz Biomed N.V., a leading provider of molecular genetics diagnostic solutions for early cancer detection, has announced a collaboration with Trusted Health Advisors (THA), a prominent player in supporting the U.S. launches and management of commercial programs for diagnostic products. The partnership with THA marks a significant step for Mainz Biomed as it prepares to advance its innovative approach to colorectal cancer (CRC) screening. The company is currently in the final stages of regulatory planning for the ReconAAsense clinical trial, aiming to obtain premarket approval (PMA) for its next-generation diagnostic test. Mainz Biomed's unique business model involves marketing products through partnerships with third-party laboratories.
Guido Baechler, Chief Executive Officer of Mainz Biomed, expressed excitement about the collaboration with THA and the opportunity it presents to enhance the company's U.S. go-to-market strategy. Baechler anticipates that the product, if approved, will make a transformative impact on the market in 2026. Dr. Jay Wohlgemuth, Managing Partner at THA, highlighted the potential of Mainz Biomed's early data for accurate detection of advanced adenoma (AA), which allows for early intervention and increases the chance of successful treatment and survival. The partnership with THA will be led by Drs. Jay Wohlgemuth and Ray Tabibiazar, who bring extensive experience in healthcare innovation and biotechnology. The THA team's capabilities span R&D through commercialization, making them valuable partners for Mainz Biomed.
