Mainz Biomed Announces Commercial Launch of ColoAlert® in Switzerland

Rhea-AI Summary

Mainz Biomed (NASDAQ:MYNZ) has announced the commercial launch of its flagship product ColoAlert® in Switzerland, marking a significant expansion of its colorectal cancer screening solution. The launch follows three key achievements: a strategic partnership with labor team w ag, one of Switzerland's leading diagnostic laboratories; regulatory approval from Swissmedic; and successful completion of technology transfer to labor team's facility in Goldach.

Additionally, the company provided an update on its eAArly DETECT 2 Study, which aims to enroll 2,000 average-risk patients. Management has decided to proceed with complete enrollment through the end of 2025 without pausing for an interim readout.

Positive

• Successful commercial launch of ColoAlert in Switzerland, expanding market presence
• Strategic partnership secured with leading Swiss diagnostic laboratory labor team w ag
• Obtained Swissmedic regulatory approval for marketing and distribution
• Completed technology transfer enabling local processing of samples in Switzerland

Negative

• Decision to forgo interim study readout may delay result availability
• Study enrollment continuing through end of 2025, indicating extended timeline for complete results

Insights

Biotechnology Market Analyst

Mainz Biomed's ColoAlert launch in Switzerland expands market reach; clinical study enrollment continues without interim analysis.

Mainz Biomed has achieved a significant commercial milestone with the launch of ColoAlert® in Switzerland, expanding the market footprint for its colorectal cancer screening test. The company has methodically built the foundation for this launch through three critical steps: securing a strategic partnership with labor team w ag (a leading Swiss diagnostic laboratory), obtaining Swissmedic regulatory approval, and completing technology transfer to enable local processing.

The partnership with labor team w ag provides Mainz with an established distribution channel through one of Switzerland's premier diagnostic networks, potentially accelerating market penetration without building infrastructure from scratch. This asset-light commercialization strategy mirrors approaches used by successful diagnostic companies to maximize return on investment while minimizing capital requirements.

The technology transfer component is particularly noteworthy as it enables processing of ColoAlert samples directly within Switzerland. This localized testing capability typically improves turnaround times, reduces logistical complexities, and often increases physician and patient acceptance rates compared to tests that must be shipped internationally.

Regarding the eAArly DETECT 2 study, management's decision to forgo an interim analysis in favor of completing the full 2,000-patient enrollment indicates confidence in maintaining the timeline for study completion by year-end 2025. While interim analyses can provide early signals of efficacy or futility, they also add complexity and potential statistical challenges. The decision to proceed directly to final analysis suggests management is prioritizing statistical robustness and comprehensive data collection over early glimpses at results.

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.

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 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 media inquiries
MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com

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.

FAQ

What is the significance of Mainz Biomed's (MYNZ) ColoAlert launch in Switzerland?

The launch represents a significant market expansion, backed by Swissmedic approval and partnership with labor team w ag, enabling Swiss-wide access to their colorectal cancer screening solution.

How will ColoAlert be distributed in Switzerland?

ColoAlert will be distributed through labor team w ag's established laboratory network, with samples processed at their state-of-the-art facility in Goldach, Switzerland.

What is the status of Mainz Biomed's eAArly DETECT 2 Study?

The study is actively recruiting towards its 2,000 patient goal, with enrollment planned through end of 2025. Management has decided to complete the full study before conducting the readout.

What regulatory approvals has Mainz Biomed (MYNZ) received for ColoAlert in Switzerland?

Mainz Biomed has received official registration and marketing approval from Swissmedic, the Swiss authority responsible for therapeutic product regulation.

Who is Mainz Biomed's strategic partner for ColoAlert in Switzerland?

Mainz Biomed has partnered with labor team w ag, one of Switzerland's leading diagnostic laboratories, to process and distribute ColoAlert tests.