Mainz Biomed Enrolls First Patient in Its eAArly DETECT 2 Clinical Study
BERKELEY, US – MAINZ, Germany – March 27, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the first patient has been enrolled in eAArly DETECT 2, a feasibility study to evaluate the Company’s next-generation colorectal cancer (CRC) test. The test integrates its proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to CRC prevention.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line 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 and APL 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.
“The first patient-in milestone marks the conclusion of several months of intensive preparatory work to ensure the trial is optimally managed and signifies the formal commencement of the study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This clinical trial is particularly exciting for the Company, the patient community, and the medical professionals alike. By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates.”
The five novel gene expression (mRNA) biomarkers, which the Company acquired from Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas – curable precancerous colonic polyps – as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed’s proprietary algorithm to enhance product specifications, extending its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC.