Mainz Biomed has received official registration from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its DNA-based colorectal cancer (CRC) screening test, ColoAlert. The approval authorises the test for marketing across the United Kingdom.

The milestone follows a technology partnership announced earlier this year with UK-based EDX Medical Group, and marks a step toward broader patient access to ColoAlert.

Colorectal cancer is the fourth most common cancer in the UK, with around 44,000 new cases each year. The national Bowel Cancer Screening Programme currently invites approximately 4 million people aged 50 to 74 to complete a faecal immunochemical test (FIT) annually. ColoAlert offers a complementary, non-invasive option by detecting DNA biomarkers in stool samples, potentially improving participation rates in early detection.

“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 company said expanding access to ColoAlert in the UK underscores its commitment to advancing innovative diagnostics. Equipping both healthcare providers and patients with additional screening tools could help address one of the leading causes of cancer-related mortality worldwide.

Mainz Biomed specialises in molecular genetic diagnostic tests for early cancer detection and has focused on making stool-based CRC screening accessible to wider populations. The company continues to build partnerships across Europe and beyond as it scales up the reach of ColoAlert.