Mainz Biomed N.V. announced that its pre-submission filed with the U.S. Food & Drug Administration (FDA) for ColoAlert has been accepted for review. By accepting the pre-submission for review, the FDA will provide feedback to the Company on its proposed pivotal U.S. clinical trial design for ColoAlert, its highly efficacious, and easy-to-use detection test for colorectal cancer (CRC). The FDA feedback is expected in calendar second quarter of 2022, and will offer Mainz the opportunity to gain preliminary insight and guidance on the potential technical parameters and endpoints of the study, which is on track to commence in 2023.

A key component of Mainz's U.S. regulatory strategy for ColoAlert is based on the outcome of the Company's recently announced (February 4, 2022) launch of ColoFuture, an international clinical study evaluating the potential to integrate a portfolio of in-licensed novel mRNA biomarkers into the product. The rationale behind acquiring the rights to these five biomarkers from the Université de Sherbrooke in December of 2021, was based on their documented, unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage CRC (Herring et al 2021). ColoFuture is evaluating the effectiveness of these biomarkers to enhance ColoAlert's technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert's rates of diagnostic sensitivity and specificity.

So, if the study results from ColoFuture prove positive, it will solidify ColoAlert as the gold standard at-home diagnostic tool for CRC currently being marketed across Europe and enable Mainz to incorporate these biomarkers into ColoAlert prior to commencing its U.S. pivotal study for the product. Mainz is currently marketing ColoAlert through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility.