Mainz Biomed to Present New Pooled Colorectal Cancer Screening Data, its Largest Study to Date, at ASCO 2024 Annual Meeting

Core Insights - Mainz Biomed N.V. announced significant findings from the ColoFuture and eAArly DETECT studies, demonstrating a sensitivity of 92.3% for colorectal cancer and 82.3% for advanced precancerous lesions [1][2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with its flagship product being ColoAlert®, a non-invasive test for colorectal cancer [6] - The company is preparing for a pivotal FDA clinical study to gain regulatory approval for its products in the U.S. market [6] Study Details - The combined analysis from the ColoFuture and eAArly DETECT studies involved 690 subjects across 30 clinical sites, making it the largest dataset to date for this type of research [2] - The studies utilized a novel stool-based approach that integrates mRNA biomarkers and the Fecal Immunochemical Test (FIT) with an AI-generated algorithm to enhance diagnostic performance [2][4] Presentation Information - The findings will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, highlighting the test's significant improvement over existing non-invasive methods for detecting advanced precancerous lesions [3] 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 [5] - In the U.S., approximately 16.6 million colonoscopies are performed annually, yet about one-third of residents aged 50-75 have never been screened, representing a market opportunity exceeding $4.0 billion [5]