Mainz BioMed Reports Pioneering Study Results in Colorectal Cancer Testing

Mainz Biomed N.V., a molecular genetics diagnostics company, disclosed remarkable topline results from their latest pooled clinical study focusing on novel mRNA biomarkers and a proprietary AI algorithm for early colorectal cancer (CRC) detection. The study revealed a sensitivity of 92% for colorectal cancer and 90% specificity, with an advanced adenoma sensitivity of 82%, positioning it best-in-class compared to existing diagnostics.

This study included 690 subjects from previously conducted trials across two continents, marking a significant advancement in non-invasive CRC screening. CEO Guido Baechler emphasized the study’s potential to refine the company’s next-generation CRC screening tools, enhancing early detection and diagnostic accuracy.

Mainz Biomed plans to present these findings at a major medical conference and continue with the FDA PMA pivotal study designed to involve up to 15,000 patients. This development could significantly impact the CRC diagnostic market, especially considering the high prevalence of CRC in the U.S. and Europe. The company aims for its next-generation test to set a new standard for non-invasive home CRC screening.