Mainz Biomed Receives Swiss Regulatory Approval to Market ColoAlert®
BERKELEY, Calif. and MAINZ, Germany, Aug. 13, 2025 (GLOBE NEWSWIRE) -- 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.
“We are pleased to receive regulatory approval in Switzerland,” said Guido Baechler, CEO of Mainz Biomed. “This supports our broader strategy to expand access to reliable CRC screening solutions for early detection for this devastating disease and ultimately to decrease related mortality rates.”
Mainz Biomed continues to focus on expanding ColoAlert®'s reach through decentralized partnerships with laboratories and regional healthcare providers—ensuring broad access and localized implementation of its advanced molecular diagnostics.
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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit or follow us on , and .
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