Mainz Biomed launches ColoAlert® in Switzerland, enhancing colorectal cancer screening access through a partnership with labor team w ag.
Quiver AI Summary
Mainz Biomed N.V. has announced the commercial launch of its colorectal cancer detection product, ColoAlert®, in Switzerland, following key developments that support its introduction. The company established a strategic partnership with labor team w ag, a prominent diagnostic laboratory in Switzerland, which will facilitate the test's availability to patients and healthcare providers. ColoAlert® has received regulatory approval from Swissmedic, allowing for its distribution in the country. Additionally, Mainz Biomed completed a successful technology transfer with labor team, enabling local processing of test samples, which enhances operational efficiency and diagnostic quality. The company is also progressing with its patient study, aiming to complete enrollment by the end of 2025 without pausing for interim results.
Potential Positives
- Mainz Biomed has officially launched its flagship product, ColoAlert®, in Switzerland, significantly enhancing patient access to innovative colorectal cancer screening solutions.
- The partnership with labor team w ag, a leading diagnostic laboratory, provides a strong foundation for the successful introduction of ColoAlert®, ensuring trust and established distribution channels.
- Official registration and marketing approval granted by Swissmedic mark a critical regulatory milestone for the company, enabling distribution in Switzerland.
- The completion of a comprehensive technology transfer with labor team ensures operational efficiency and high-quality diagnostics within the Swiss healthcare system.
Potential Negatives
- The press release includes a significant cautionary statement about the uncertainties and risks associated with the company's forward-looking statements, which could create concerns for investors regarding the reliability of the company's projections and future performance.
- The decision not to pause the 2,000 patient study for an interim readout may raise questions about the company's risk management and data analysis strategy, potentially leading to skepticism among stakeholders about the approach to this critical research.
- The emphasis on the need for "caution" in relying on projections may indicate underlying challenges that could affect stakeholder confidence in the company's growth and operational strategy.
FAQ
What is ColoAlert®?
ColoAlert® is an accurate, non-invasive diagnostic test for the early detection of colorectal cancer developed by Mainz Biomed.
Where is ColoAlert® being launched?
ColoAlert® has been commercially launched in Switzerland, marking an essential step towards expanding patient access.
Who partnered with Mainz Biomed for this launch?
Mainz Biomed partnered with labor team w ag, a leading diagnostic laboratory in Switzerland, for the successful introduction of ColoAlert®.
What regulatory approval has ColoAlert® received?
ColoAlert® received official registration and marketing approval from Swissmedic, allowing its distribution in Switzerland.
What is Mainz Biomed's future clinical study focus?
Mainz Biomed is focused on a 2,000 patient study for average risk populations, aiming for enrollment completion by the end of 2025.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
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
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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.
