Mainz Biomed's ColoAlert Receives Swissmedic Approval, Paving Way For Swiss Launch Of Non-Invasive Colorectal Cancer Test

Mainz Biomed N.V. (NASDAQ:MYNZ) ("Mainz Biomed" or the "Company"), a molecular genetics diagnostic company specializing in the early detection of cancer, announces today that ColoAlert®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.

In Switzerland, CRC screening programs primarily focus on individuals between the ages of 50 and 74, with options for a biennial Fecal Immunochemical Test (FIT) or a colonoscopy every 10 years. The population in the 50 to 74 age group is estimated at around 2.8 million, accounting for approximately 31.4% of Switzerland's total inhabitants. Despite the presence of over 13 screening programs nationwide, current participation rates fall below 50%. The introduction of innovative early detection test for colorectal cancer, such as ColoAlert, could significantly contribute to improving participation rates, supporting national health goals, and addressing a critical gap in prevention efforts.

The regulatory approval by Swissmedic follows the Company's previously announced partnership with a local laboratory in Switzerland, labor team w ag, earlier this year. With this milestone, ColoAlert® is now authorized for use in the Swiss market and will be made available through the partner laboratory's diagnostic service offering, with no remaining obstacles to the upcoming launch.

ColoAlert® is a non-invasive screening test which is currently marketed in select countries across Europe and is designed to detect CRC tumor DNA and other biomarkers with high sensitivity in stool samples.