Mainz Biomed Presented Industry Leading Results of its Pooled Study at ASCO 2024

Core Insights - Mainz Biomed's mRNA biomarkers have demonstrated high sensitivity for colorectal cancer (CRC) detection at 92% and 82% for advanced adenomas, with a notable 95.8% detection rate for high-grade dysplasia, confirming the effectiveness of their innovative screening approach [1][3][4] Company Overview - Mainz Biomed N.V. specializes in molecular genetics diagnostics for early cancer detection, with its flagship product, ColoAlert®, being a non-invasive test for CRC based on real-time PCR detection of biomarkers in stool samples [7] - The company is preparing for a pivotal FDA clinical study to gain regulatory approval for its products in the U.S. market [7] Study Details - The combined analysis included 690 clinical subjects from 30 specialized gastroenterology centers in Europe and the U.S., showcasing the efficacy of Mainz Biomed's multimodal screening test that integrates the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers and advanced AI algorithms [2][5] - The study results were presented at the ASCO 2024 Annual Meeting, highlighting the significant advantages of the multimodal screening test over existing methods, particularly in detecting advanced precancerous lesions [3][4] Market Context - Colorectal cancer is the third most common cancer globally, with over 1.9 million new cases reported in 2020, indicating a substantial market opportunity for effective screening solutions [6] - The U.S. market presents a $4.0 billion opportunity due to a significant gap in screening, with approximately one-third of U.S. residents aged 50-75 never having been screened for colon cancer [6]