Berkeley, CA / Mainz, Germany: Mainz Biomed N.V., a leading molecular genetics diagnostics company specializing in early cancer detection, announced that it will provide an interim readout for its ongoing eAArly DETECT 2 feasibility study by the end of summer 2025.
This marks a major milestone in the company’s mission to advance early colorectal cancer (CRC) screening and prevention.
The eAArly DETECT 2 study evaluates Mainz Biomed’s next-generation CRC screening test, which integrates its proprietary mRNA biomarkers, an AI-powered algorithm, and a fecal immunochemical test (FIT).
The study involves approximately 2,000 average-risk patients and builds on the strong performance of previous feasibility studies.
“We are thrilled with the momentum of eAArly DETECT 2 and look forward to delivering an interim update to our partners and stakeholders,” said Guido Baechler, CEO of Mainz Biomed. “This trial underscores our dedication to eliminating colorectal cancer through early, accurate detection.”
The company aims to complete enrollment in the second half of 2025, with final top-line results expected by Q4 2025. These results will shape the protocol for ReconAAsense—Mainz Biomed’s U.S. pivotal clinical trial, which is scheduled to begin in 2026.
Mainz Biomed: Innovative CRC Screening Approach
Mainz Biomed’s innovative CRC screening approach combines five proprietary mRNA biomarkers—licensed from Sherbrooke University in 2022—with advanced AI and diagnostic tools.
These biomarkers are uniquely capable of detecting both early-stage colorectal cancer and curable precancerous lesions such as advanced adenomas.
Through eAArly DETECT 2, the company aims to confirm its test’s sensitivity and specificity, expanding its diagnostic capabilities and contributing to the growing global movement for preventative cancer care.
The initiative is poised to redefine colorectal cancer screening by enabling earlier diagnosis and intervention, which could significantly reduce mortality rates and healthcare costs associated with late-stage cancer.
