Mainz Biomed Announces Commercial Launch of ColoAlert® in Switzerland

Company Provides Update on eAArly DETECT 2 Study
 

BERKELEY, US and MAINZ, Germany – September 23, 2025 - 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.
 
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. The Company is currently running its eAArly DETECT 2 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.
 
For investor inquiries, please contact ir@mainzbiomed.com