Mainz Biomed Announces Registration of ColoAlert in the United Kingdom

Mainz Biomed Announces Registration of ColoAlert in the United Kingdom

BERKELEY, US and MAINZ, Germany – September 2, 2025 - 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.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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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 mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Maximilian Schur / Simone Neeten
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mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.