ColoAlert® Launch: Mainz Biomed's New Era in Cancer Detection

Mainz Biomed Announcement - ColoAlert® Launch in Switzerland

Mainz Biomed N.V. (NASDAQ: MYNZ), a cutting-edge molecular genetics diagnostic company focused on cancer detection, recently marked a significant milestone with the commercial launch of its flagship product, ColoAlert®, in Switzerland. This advancement is aimed at bolstering the fight against colorectal cancer, a disease affecting many globally.

Strategic Partnerships for Successful Launch

The success of ColoAlert®’s introduction in Switzerland is anchored in a strategic partnership with labor team w ag, a prominent diagnostic laboratory known for its reliable healthcare solutions. This collaboration guarantees that ColoAlert® will be effectively distributed, giving healthcare professionals and patients access to a trusted screening method.

Ensuring Accessibility

With the backing of labor team, Mainz Biomed is creating a robust network designed to make the test readily accessible. This collective effort signifies a commitment to improving early detection practices, which can ultimately save lives by identifying cancer at a stage when it is most treatable.

Regulatory Approvals and Technology Transfer

In a critical step forward, the Swiss authority, Swissmedic, has granted regulatory approval for ColoAlert®. This crucial authorization allows for widespread distribution and signifies a major milestone in the regulatory journey of innovative cancer screening methods.

Local Sample Processing for Enhanced Patient Care

In conjunction with obtaining the registration, Mainz Biomed successfully executed a technology transfer to labor team. This process will enable the laboratory to efficiently manage and analyze ColoAlert® samples in its state-of-the-art facility in Goldach. Such capabilities are vital for delivering high-quality diagnostics and ensuring that Swiss patients receive top-notch healthcare.

Progress on Clinical Study and Future Plans

As Mainz Biomed optimistically launches ColoAlert®, it is also progressing with clinical studies aimed at enhancing its product portfolio. The company is in the process of recruiting participants for a study targeting a 2,000 patient sample, focusing on individuals with average risk. This initiative underscores Mainz Biomed’s commitment to scientific rigor and its proactive approach to research and development.

Strategic Enrollment Objectives

Management has decided to maintain momentum by not pausing the enrollment process for interim readouts. Instead, the focus will now be on completing full enrollment, followed by comprehensive analysis. This strategic choice indicates confidence in the study's design and its potential impact on future colorectal cancer screening practices.

About Mainz Biomed NV

Mainz Biomed excels in developing molecular genetic diagnostic solutions aimed at addressing life-threatening diseases. The flagship test, ColoAlert®, offers an innovative and non-invasive approach for early cancer detection in colorectal patients. This product is marketed throughout Europe, making strides toward improving cancer screening accessibility.

Exploring Additional Solutions

The future looks promising as Mainz Biomed also embarks on the eAArly DETECT clinical study, which focuses on preparing for pivotal FDA studies seeking U.S. regulatory approval. Another key product in its pipeline is PancAlert, a test designed for early-stage pancreatic cancer diagnosis through innovative real-time Polymerase Chain Reaction-based methods. These developments signify Mainz Biomed’s determination to enhance early diagnostic options for patients worldwide.

Contact Information

For media inquiries, please reach out to MC Services AG, where Maximilian Schur or Simone Neeten can assist you. Call +49 211 529252 20 or contact via email at mainzbiomed@mc-services.eu.

Investors can connect through ir@mainzbiomed.com for any inquiries regarding investment opportunities and updates.

Frequently Asked Questions

What is ColoAlert® and how does it work?

ColoAlert® is a non-invasive diagnostic test that detects early signs of colorectal cancer, providing an accessible option for patients.

Why is the launch in Switzerland significant?

The launch signifies increased accessibility to early cancer detection methods through a strategic partnership with a local diagnostic laboratory as well as regulatory approvals.

What does the technology transfer involve?

The technology transfer equips the labor team’s laboratory with the ability to process and analyze ColoAlert® samples, enhancing operational efficiency and diagnostic quality.

What is next for Mainz Biomed after the launch?

The company aims to complete patient recruitment for its clinical study and pursue future advancements in cancer diagnostics.

How can I get more information about Mainz Biomed and its products?

Visit Mainz Biomed’s official website for further details, or contact their investor relations team for inquiries.

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