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] Group 1: Study Results - The combined analysis included 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the United States, showcasing the efficacy of Mainz Biomed's multimodal screening test [2][5] - The multimodal screening test integrates the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers and advanced AI algorithms, allowing for precise differentiation among CRC, advanced adenomas, non-advanced adenomas, and samples with no pathological findings [2][3] Group 2: Presentation Details - The study was presented at the ASCO 2024 Annual Meeting, highlighting key findings such as a sensitivity of 92.3% for CRC and 82.2% for advanced precancerous lesions, with a specificity of 90.1% [3][4] - The significant improvement in sensitivity for detecting high-grade dysplasia compared to existing non-invasive tests positions this multimodal approach as a promising tool for cancer prevention [3][4] Group 3: Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product, ColoAlert®, being a non-invasive early-detection test for CRC [7] - The company is planning to conduct a pivotal FDA clinical study for regulatory approval in the U.S., aiming to transform CRC screening practices and reduce global cancer mortality rates [4][7]