Mainz Biomed Initiates U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population

Study Overview - Mainz Biomed NV launches eAArly DETECT 2, a U S feasibility study to evaluate its next-generation colorectal cancer (CRC) test, integrating mRNA biomarkers, AI algorithms, and FIT test, targeting a population of approximately 2,000 average-risk patients [1] - The study aims to validate previous feasibility study results, which included both average-risk and identified-risk patients, and is expected to complete enrollment in the second half of 2025 with topline results reported by Q4 2025 [1][2] Study Objectives and Impact - The eAArly DETECT 2 study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown unique ability to identify advanced adenomas and early-stage CRC [3] - The study aims to enhance product specifications by combining these biomarkers with Mainz Biomed's proprietary AI algorithm, potentially increasing diagnostic sensitivity and specificity for early-stage CRC [3] - Successful outcomes from the study will enable Mainz Biomed to finalize protocols for ReconAAsense, its U S pivotal study, scheduled to initiate in 2026 [2] Company Strategy and Vision - The launch of eAArly DETECT 2 is a significant milestone for Mainz Biomed, accelerating the timeline to evaluate biomarkers for inclusion in the U S pivotal study [3] - The company's next-generation CRC test aims to transform colorectal cancer screening by detecting cancerous polyps with high accuracy and potentially preventing the disease through early detection of precancerous adenomas [2][3] - Mainz Biomed's mission is to transform CRC screening practices and reduce global cancer mortality rates by enabling precise detection of advanced adenomas and early-stage CRC [3] Company Background - Mainz Biomed specializes in molecular genetics diagnostics for life-threatening conditions, with ColoAlert® as its flagship product, marketed in Europe and the UAE [4] - The company is conducting a pivotal FDA clinical study for U S regulatory approval of ColoAlert® and is developing PancAlert, an early-stage pancreatic cancer screening test [4]