Mainz Biomed NV launched eAArly DETECT 2, a U.S. feasibility study for its next-generation colorectal cancer (CRC) screening test. The study, involving approximately 2,000 average-risk patients, aims to validate earlier promising results and pave the way for a larger pivotal study, ReconAAsense, planned for 2026. The new test integrates mRNA biomarkers, an AI-driven algorithm, and a fecal immunochemical test (FIT).
This study is crucial because it could significantly advance CRC screening by potentially enabling the detection of precancerous adenomas, not just cancerous polyps. Early detection of advanced adenomas could shift the paradigm from reactive treatment to proactive prevention, drastically improving patient outcomes and reducing CRC mortality rates. Successful validation of this combined approach could also establish a new standard for non-invasive CRC screening, surpassing current FIT-based methods in sensitivity and specificity.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, with topline results anticipated in the fourth quarter of 2025. The study focuses on evaluating five novel mRNA biomarkers acquired from Sherbrooke University in 2022. These biomarkers, combined with Mainz Biomed’s proprietary AI algorithm, are expected to enhance the test’s ability to identify advanced adenomas and early-stage CRC, increasing both diagnostic sensitivity and specificity.
The results of eAArly DETECT 2 will directly inform the protocols for the pivotal ReconAAsense study. Positive results could accelerate the development and regulatory approval of this next-generation CRC screening test, positioning Mainz Biomed at the forefront of early cancer detection and potentially transforming colorectal cancer screening practices worldwide. This advancement could also lead to wider adoption of more effective screening methods, contributing to a significant decrease in global CRC incidence and mortality.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
