Mainz Biomed B.V. announced that it has successfully completed the conformity assessment of its internal processes to In Vitro Diagnostic Devices Regulation (IVDR) compliance which becomes mandatory from May 26, 2022. Additionally, the ColoAlert patient kit is now CE marked to the IVDR requirements, a significant milestone and achievement for the company. The new, harmonized IVDR regulatory framework has been established to ensure the safety and performance of in-vitro diagnostic medical
devices in the European market. Meeting conformity assessment requirements to IVDR compliance for ColoAlert, Mainz Biomed's highly efficacious, and easy-to-use detection test for colorectal cancer (CRC), involves meeting new standards for the CE mark of its stool collection tool. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company's commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country. *Dollinger MM et al. (2018) About the ColoFuture Study The ColoFuture study is an international clinical trial evaluating over 600 patients (women or men) in the age range of 40-85 at two participating centers in Norway and two in Germany. Subjects are invited to potentially participate in the trial when referred for a colonoscopy (pre-inclusion) to screen for CRC or an overall diagnostic analysis. Those who agree to provide a stool sample in advance of the procedure will be eligible for participation. Inclusion criteria are based on one of the following diagnostic outcomes: CRC, advanced precancerous lesions in colon, or normal colon. Then, each patient outcome will compare the observations recorded from the colonoscopy to the results from the ColoAlert test that incorporates the novel biomarkers. The primary endpoints of the study are to determine sensitivity and specificity rates for CRC with ColoAlert plus the new mRNA biomarkers. There are multiple secondary endpoints for evaluating the modified ColoAlert test, including, determining sensitivity for AA lesions in colon, specificity for advanced precancerous lesions in colon and, specificity for no colorectal finding (normal colon). The Company is expecting to complete enrollment during the second half of 2022 and is targeting reporting study results in early 2023. About Colorectal Cancer Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%.