Mainz Biomed N.V. announced the launch of eAArly DETECT 2, a U.S. feasibility study designed to evaluate the company’s next-generation colorectal cancer (CRC) test. This study integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test.
The study will enroll approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies, which included both average and identified risk patients. Enrollment is expected to complete in the second half of 2025, with topline results targeted for the fourth quarter of 2025.
The eAArly DETECT 2 study is a critical precursor to the ReconAAsense U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC test aims to detect cancerous polyps with high accuracy and potentially prevent the disease through early detection of precancerous adenomas.
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