Mainz Biomed Announces Commercial Launch of ColoAlert® in Switzerland
Company Provides Update on eAArly DETECT 2 Study
BERKELEY, Calif. and MAINZ, Germany, Sept. 23, 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, is pleased to announce the commercial launch of its flagship product, ColoAlert®, in Switzerland.
This milestone comes as the result of several key achievements. Earlier this year, Mainz Biomed signed a strategic partnership with labor team w ag (“labor team”), one of the country’s leading diagnostic laboratories. This collaboration provides a strong foundation for ColoAlert’s successful introduction, ensuring that patients and physicians across Switzerland will have access to the test through an established and trusted network.
Following this, Swissmedic, the Swiss authority responsible for therapeutic product regulation, granted official registration and marketing approval for ColoAlert®. This authorization enables the test to be distributed in Switzerland and marks an important regulatory step toward expanding patient access to innovative colorectal cancer screening solutions.
In addition, Mainz Biomed successfully completed a comprehensive technology transfer with labor team, enabling the laboratory to process and analyze ColoAlert® samples directly at its state-of-the-art facility in Goldach, Switzerland. This local implementation not only ensures operational efficiency but also guarantees that Swiss patients benefit from high-quality diagnostics performed within their own healthcare system.
Together, these accomplishments have paved the way for the commercial launch of ColoAlert®, making the test available to patients and healthcare providers throughout Switzerland.
The Company continues to make progress on recruitment for its 2,000 patient, average risk population study. With its goal of completing enrollment by the end of 2025, management has decided not to pause the study for an interim readout, but instead completing enrollment, analysis, and read out on the completed study.
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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. The Company is currently running its eAArly DETECT clinical study in preparation for it pivotal FDA 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 blood and 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.
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