BERKELEY, Calif. and MAINZ, Germany, Aug. 13, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic firm focused on early cancer detection, today announced that Swissmedic, Switzerland’s regulatory and supervisory body for medicinal products and medical devices, has officially registered and approved ColoAlert®, its non-invasive screening test for colorectal cancer (CRC), for distribution.

Swiss CRC screening initiatives primarily target individuals aged 50 to 74, offering either a Fecal Immunochemical Test (FIT) every two years or a colonoscopy once every decade. This demographic, aged 50-74, comprises an estimated 2.8 million people, representing about 31.4% of Switzerland’s overall population. Despite more than 13 screening programs operating across the country, participation rates currently remain under 50%. Introducing advanced early detection tests for colorectal cancer, like ColoAlert, has the potential to substantially boost participation, support national health objectives, and fill a vital gap in current prevention strategies.

Swissmedic’s regulatory approval comes after the Company’s earlier announcement this year of a partnership with labor team w ag, a local laboratory in Switzerland. This achievement means ColoAlert® is now cleared for the Swiss market and will be offered via the partner laboratory’s diagnostic services, clearing the way for its imminent launch.

ColoAlert® is a non-invasive screening method currently sold in various European countries. It is designed to highly sensitively detect CRC tumor DNA and other biomarkers within stool samples.

“We are delighted to obtain regulatory approval in Switzerland,” stated Guido Baechler, CEO of Mainz Biomed. “This aligns with our wider strategy to broaden access to dependable CRC screening solutions for early detection of this severe disease and, in the long term, to reduce associated mortality rates.”

Mainz Biomed remains committed to extending ColoAlert®‘s availability by establishing decentralized collaborations with laboratories and regional healthcare providers, thereby ensuring widespread access and localized deployment of its sophisticated molecular diagnostics.

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About Mainz Biomed NV
Mainz Biomed creates market-ready molecular genetic diagnostic tools for critical health conditions. The Company’s primary product is ColoAlert®, a precise, non-invasive, and user-friendly diagnostic test for the early detection of colorectal cancer. ColoAlert® is sold throughout Europe and the United Arab Emirates. The Company is presently conducting a pivotal FDA clinical study to secure US regulatory approval. Mainz Biomed’s pipeline also features PancAlert, an early-stage pancreatic cancer screening test utilizing real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. For more information, visit or follow us on , and .

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