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Mainz Biomed Enrolls First Patient in eAArly DETECT Study Evaluating Integration of Novel mRNA Biomarkers Into ColoAlert

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Mainz Biomed NV (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, Mainz’s U.S. extension of ColoFuture, its European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert. Currently, Mainz is commercializing ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) across Europe and in select international territories. ColoFuture/eAArly DETECT are multi-center studies assessing the potential of these biomarkers to identify advanced adenomas, a type of pre-cancerous polyp often attributed to CRC.

“Given the transformational impact that integrating advanced adenoma detection will have on ColoAlert’s technical profile and ultimate role in helping CRC prevention and treatment, today’s milestone is important as we embark on the execution phase of this feasibility study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “All of us involved with Mainz are excited by the prospect of incorporating these biomarkers into ReconAAsense, our U.S. pivotal study to evaluate the clinical performance of ColoAlert which we anticipate commencing patient enrollment in H1 2023.”

The five novel gene expression (mRNA) biomarkers being evaluated in the eAArly DETECT/ColoFuture studies were in-licensed from the Université de Sherbrooke, Quebec, Canada (January 2022). In the institution’s pioneering work, researchers tested a battery of novel transcriptional biomarkers using colon cancer samples and precancerous lesions. The five mRNA targets chosen by Mainz Biomed provided the greatest sensitivity and specificity of detection (Herring et al. 2021) and demonstrated a unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC. The eAArly DETECT study will evaluate the effectiveness of these biomarkers to enhance ColoAlert’s product specifications to extend its capability to include the identification of advanced adenomas while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.

Mainz expects to complete enrollment for the eAArly DETECT in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, the Company will determine which of the biomarkers are eligible for inclusion in the Company’s U.S. pivotal trial (ReconAAsense), which is on schedule to begin enrolling patients in 2023 with results expected in 2025.