The DNA-based stool screening test is now authorized for marketing through the MHRA, expanding access to non-invasive CRC detection.
Mainz Biomed NV has received official registration from the Medicines and Healthcare products Regulatory Agency (MHRA) for its ColoAlert colorectal cancer screening test, authorizing the company to market the DNA-based diagnostic in the United Kingdom (UK).
The regulatory approval enables Mainz Biomed’s UK laboratory partner, EDX Medical Group plc, to offer the non-invasive stool-based test to patients across the country. The companies announced their technology partnership earlier this year.
ColoAlert detects DNA biomarkers in stool samples to screen for colorectal cancer, providing laboratories with an alternative to existing screening methods. The test aims to complement the UK’s current Bowel Cancer Screening Program, which invites approximately 4 million people aged 50 to 74 to complete fecal immunochemical tests annually.
“With the approval, ColoAlert is now cleared for use across the UK,” says Guido Baechler, CEO of Mainz Biomed, in a release. “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.”
Addressing a Significant Disease Burden
Colorectal cancer represents the fourth most common cancer in the UK, with approximately 44,000 new cases diagnosed annually. The addition of ColoAlert to available screening options could help laboratories increase testing participation rates by providing patients with an accessible diagnostic alternative.
The molecular genetics diagnostic company currently markets ColoAlert across Europe and the United Arab Emirates. Mainz Biomed is conducting a pivotal US Food and Drug Administration clinical study for US regulatory approval of the test.
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