The Company has issued an update concerning the eAArly DETECT 2 Study.
BERKELEY, Calif. and MAINZ, Germany, Sept. 23, 2025 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic firm specializing in the early detection of cancer, is delighted to announce the commercial introduction of its leading product, ColoAlert®, in Switzerland.
This significant achievement follows a series of important accomplishments. Earlier this year, Mainz Biomed established a strategic collaboration with labor team w ag (“labor team”), recognized as one of Switzerland’s foremost diagnostic laboratories. This partnership creates a robust framework for ColoAlert’s effective deployment, guaranteeing that patients and healthcare providers throughout Switzerland can access the test via an established and reliable network.
Subsequent to these developments, Swissmedic, the Swiss regulatory body for therapeutic products, officially granted registration and marketing authorization for ColoAlert®. This approval allows the test to be distributed within Switzerland and signifies a crucial regulatory advancement aimed at broadening patient access to novel colorectal cancer screening options.
Furthermore, Mainz Biomed successfully concluded a comprehensive technology transfer with labor team, empowering the laboratory to process and analyze ColoAlert® samples firsthand at its advanced facility in Goldach, Switzerland. This localized setup not only enhances operational efficiency but also assures that Swiss patients receive high-quality diagnostics conducted within their national healthcare system.
Collectively, these achievements have facilitated the commercial introduction of ColoAlert®, making the test readily available to patients and healthcare providers across Switzerland.
The Company is actively advancing recruitment for its 2,000-patient study, focusing on an average-risk population. With the objective of finalizing enrollment by the close of 2025, management has opted to proceed directly to the full completion of enrollment, analysis, and readout for the entire study, rather than pausing for an interim data disclosure.
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About Mainz Biomed NV
Mainz Biomed specializes in creating market-ready molecular genetic diagnostic solutions for serious health conditions. Its primary product is ColoAlert®, an accurate, non-invasive, and user-friendly diagnostic test designed for the early detection of colorectal cancer. ColoAlert® is currently marketed across Europe. The Company is presently conducting its eAArly DETECT clinical study, which is a precursor to its pivotal FDA study required for US regulatory approval. Mainz Biomed’s product pipeline also encompasses PancAlert, an early-stage pancreatic cancer screening test that utilizes real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers found in blood and stool samples. To learn more, visit or follow us on , and .
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