Mainz Biomed N.V. will present an analysis from its eAArly DETECT study at Digestive Disease Week (DDW) 2024 in Washington D.C. from May 18th to May 21st. eAArly DETECT is a US multi-site study performed at 21 specialized gastroenterology sites that enrolled 254 clinical patients. The results show compelling performance of its multimodal screening test combining Fecal Immunochemical Test (FIT), DNA and mRNA biomarkers with a unique artificial intelligence (AI) /machine learning algorithm to differentiate between colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas and patient samples with no findings.

The presentation will delve into the test's ability to accurately analyze a combination of biomarkers, improving early detection rates for both colorectal cancer and significant precancerous conditions. By leveraging this dual approach, Mainz Biomed aims to accelerate the shift from cancer detection to prevention by advancing current colorectal cancer screening practices, reflecting its commitment to reducing cancer mortality rates worldwide. The eAArly DETECT was performed to identify novel mRNA biomarker for potential integration into the Mainz Biomed's pivotal FDA PMA clinical trial ReconAAsense.

The study enrolled 254 evaluable subjects across 21 sites in the U.S. with a similar design to that of ColoFuture, its European counterpart. Patients aged 45 years and older were invited to participate when referred for a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Those who agreed to provide a stool sample in advance of the colonoscopy (or treatment in the case of subjects with already identified colorectal cancer) were eligible for participation.

Subjects were classified into groups following central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the ColoAlert®? test incorporating the novel biomarkers.