Mainz Biomed Receives Swiss Regulatory Approval to Market ColoAlert®
BERKELEY, Calif. and MAINZ, Germany, Aug. 13, 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®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
In Switzerland, CRC screening programs primarily focus on individuals between the ages of 50 and 74, with options for a biennial Fecal Immunochemical Test (FIT) or a colonoscopy every 10 years. The population in the 50 to 74 age group is estimated at around 2.8 million, accounting for approximately 31.4% of Switzerland's total inhabitants. Despite the presence of over 13 screening programs nationwide, current participation rates fall below 50%. The introduction of innovative early detection test for colorectal cancer, such as ColoAlert, could significantly contribute to improving participation rates, supporting national health goals, and addressing a critical gap in prevention efforts.
The regulatory approval by Swissmedic follows the Company's previously announced partnership with a local laboratory in Switzerland, labor team w ag, earlier this year. With this milestone, ColoAlert® is now authorized for use in the Swiss market and will be made available through the partner laboratory's diagnostic service offering, with no remaining obstacles to the upcoming launch.
ColoAlert® is a non-invasive screening test which is currently marketed in select countries across Europe and is designed to detect CRC tumor DNA and other biomarkers with high sensitivity in stool samples.
"We are pleased to receive regulatory approval in Switzerland," said Guido Baechler, CEO of Mainz Biomed. "This supports our broader strategy to expand access to reliable CRC screening solutions for early detection for this devastating disease and ultimately to decrease related mortality rates."
Mainz Biomed continues to focus on expanding ColoAlert®'s reach through decentralized partnerships with laboratories and regional healthcare providers—ensuring broad access and localized implementation of its advanced molecular diagnostics.
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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.
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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.
