Mainz Biomed initiates U.S. study to evaluate CRC test

Mainz Biomed (MYNZ) announced the launch of eAArly DETECT 2, a U.S. feasibility study to evaluate the Company’s next generation colorectal cancer, CRC, test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the industry leading results of previous feasibility studies, which included average risk and identified risk patients. The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025 and the Company targets reporting topline results by the fourth quarter of 2025. Based on the study’s outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company’s U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.