Mainz Biomed Announces Registration of ColoAlert in the United Kingdom
BERKELEY, Calif. and MAINZ, Germany, Sept. 02, 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® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
This milestone follows the technology partnership announced earlier this year with EDX Medical Group plc, a leading UK laboratory, and represents an important step toward making Mainz Biomed’s DNA-based colorectal cancer (CRC) screening test, ColoAlert, broadly accessible to patients across the country.
Colorectal cancer is the fourth most common cancer in the UK, with approximately 44,000 new cases diagnosed annually. ColoAlert provides a non-invasive approach to CRC screening by detecting DNA biomarkers in stool samples. The test aims to complement the existing Bowel Cancer Screening Program, which currently invites around 4 million people aged 50 to 74 to complete a FIT test annually, by providing an additional, accessible option that could help increase participation.
“With the approval, ColoAlert is now cleared for use across the UK,” said Guido Baechler, CEO of Mainz Biomed. “This regulatory milestone enables our UK laboratory partner to provide a reliable and user-friendly test to a large population, supporting our shared goal of increasing participation in preventive screening and, ultimately, saving more lives.”
The approval of ColoAlert in the UK underscores Mainz Biomed’s commitment to expanding access to innovative diagnostic solutions for early cancer detection. By equipping healthcare providers and patients with an additional tool for colorectal cancer prevention, the Company continues to advance its mission of addressing one of the leading causes of cancer-related mortality worldwide.
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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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