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Mainz Biomed Announce IRB Approval and Initiation of US Pivotal FDA Clinical Study

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Mainz Biomed NV, a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense, the Company’s US pivotal study to evaluate the clinical performance of its highly efficacious and easy-to-use detection test for colorectal cancer (CRC). Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the US Food and Drug Administration (FDA) to achieve marketing authorization.

ReconAAsense is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and advanced adenomas (AA).

Integral to the Company’s development strategy concerning the evolution of the product’s specifications is the potential to upgrade its technical profile to achieve a transformational advancement in self-administered CRC screening. To this end, Mainz Biomed recently initiated eAArly DETECT, its US extension of ColoFuture, the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into its next-generation product. These biomarkers have demonstrated a unique ability to identify precancerous colonic polyps and early-stage CRC (Herring et al., 2021). The eAArly DETECT study was initiated in November of 2022 and is evaluating the effectiveness of these biomarkers to enhance product specifications to extend its capability to include the detection of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for colorectal cancer. Mainz Biomed expects to complete eAArly DETECT enrollment in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, Mainz Biomed will decide on the integration of the biomarkers evaluated in ColoFuture’s eAArly DETECT into the ReconAAsense study.

“Given that colorectal cancer continues to be one of the deadliest forms of cancer, early detection plays a critical role in disease prevention and treatment,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “We look forward to commencing the U.S. regulatory approval process for our next-generation product and are passionate about bringing this easy-to-administer test to the U.S. In addition, we eagerly await results from the ColoFuture feasibility study, as the potential to include novel biomarkers to detect advanced adenomas will be a game changer for at-home CRC screenings.”

Once enrollment commences, ReconAAsense will continue until at least 73 evaluable subjects are diagnosed with colorectal cancer, and at least 138 evaluable subjects are diagnosed with advanced adenoma. Details about the ReconAAsense study will soon be online at clinicaltrials.gov. The Company anticipates reporting results in 2025.