BERKELEY, Calif. and MAINZ, Germany, Sept. 02, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced that ColoAlert® has achieved official registration with the Medicines and Healthcare products Regulatory Agency (MHRA), thereby authorizing its marketing in the United Kingdom.
This achievement follows the technology partnership unveiled earlier this year with EDX Medical Group plc, a prominent UK laboratory, and signifies a crucial advance towards making Mainz Biomed’s DNA-based colorectal cancer (CRC) screening test, ColoAlert, broadly accessible to patients across the nation.
Colorectal cancer stands as the fourth most common cancer in the UK, with roughly 44,000 new diagnoses reported annually. ColoAlert offers a non-invasive method for CRC screening by identifying DNA biomarkers in stool samples. The test aims to complement the existing Bowel Cancer Screening Program, which currently invites approximately 4 million individuals aged 50 to 74 for an annual FIT test, by introducing an additional, convenient option that could enhance participation.
“With this approval, ColoAlert is now cleared for use throughout the UK,” stated Guido Baechler, CEO of Mainz Biomed. “This regulatory milestone enables our UK laboratory partner to provide a dependable and user-friendly test to a large populace, supporting our mutual objective of increasing engagement in preventative screening and, ultimately, preserving more lives.”
The UK approval for ColoAlert highlights Mainz Biomed’s dedication to broadening access to advanced diagnostic options for early cancer identification. By furnishing healthcare professionals and patients with an extra resource for colorectal cancer prevention, the Company is progressing its mission to tackle a primary global cause of cancer-related deaths.
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About Mainz Biomed NV
Mainz Biomed specializes in creating molecular genetic diagnostic solutions ready for market that address life-threatening illnesses. Its primary product, ColoAlert®, is a precise, non-invasive, and user-friendly diagnostic test for the early detection of colorectal cancer. ColoAlert® is currently sold throughout Europe and the United Arab Emirates. The Company is presently conducting a crucial FDA clinical trial to secure US regulatory clearance. Mainz Biomed’s pipeline also features PancAlert, a screening test for early-stage pancreatic cancer, which utilizes real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers found in stool samples. For further details, visit or connect with us on , and .
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Forward-Looking Statements
This press release contains certain “forward-looking statements” as defined by the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements are often identified by terms like “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project,” alongside other similar phrases that forecast or suggest future occurrences or trends, rather than recounting historical facts. These forward-looking statements represent the Company’s current evaluation of available information and are subject to various inherent risks and uncertainties. Consequently, prudence is advised when depending on these statements. Due to both identified and unidentified risks, actual outcomes may substantially diverge from the Company’s anticipated results or forecasts. Among other factors, the following could lead to actual results differing significantly from those expressed in these forward-looking statements: (i) an inability to achieve planned development and associated objectives; (ii) alterations in relevant laws or regulations; (iii) the impact of the COVID-19 pandemic on the Company and its existing or prospective markets; and (iv) other risks and uncertainties detailed herein, as well as those periodically addressed in other reports and public submissions to the Securities and Exchange Commission (the “SEC”) by the Company. Further details regarding these and other factors that might influence the Company’s expectations and projections are available in its initial SEC filings, including its annual report on Form 20-F filed on March 31, 2025. The Company’s SEC filings are publicly accessible on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release relies solely on information currently accessible to Mainz Biomed and is valid only as of its creation date. Mainz Biomed disclaims any obligation to publicly revise any forward-looking statement, whether in writing or orally, that may be issued from time to time, whether due to new information, future developments, or other reasons, except where legally mandated.
