Mainz Biomed and GANZIMMUN Announce Launch of Enhanced ColoAlert Colorectal Cancer Screening Ahead of Awareness Month

Mainz Biomed and GANZIMMUN Announce Launch of Enhanced ColoAlert Colorectal Cancer Screening Ahead of Awareness Month
Updated Screening Guidelines Ensure Broader Access to Colorectal Cancer Screening in Germany

BERKELEY, US and MAINZ, Germany – February 11, 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 share that its partner, GANZIMMUN Diagnostics, has officially launched the enhanced ColoAlert colorectal cancer (CRC) screening test. Starting this January, patients across Germany can access this new version of the Company’s screening test, in time for Colorectal Cancer Awareness Month in March.

First introduced by Mainz Biomed in mid-2024, the enhanced ColoAlert features state-of-the-art advancements, including a proprietary DNA stabilizing buffer, to deliver accurate results even with varying sample volumes.

This collaborative launch reaffirms both companies’ shared dedication to advancing colorectal cancer prevention through innovation and accessibility. “This milestone brings us closer to our mission of improving colorectal cancer prevention and detection,” said Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed. “We are thrilled to support GANZIMMUN in making this pioneering test available to patients at such a critical time for cancer awareness.”

Boosting Awareness and Accessibility with Unified Screening Guidelines

The launch coincides with March Colorectal Cancer Awareness Month, a global initiative emphasizing the importance of early detection in fighting one of the most preventable cancers. This strategic timing highlights the critical role innovative diagnostics like ColoAlert play in saving lives.

Furthermore, the enhanced ColoAlert is launching at a time when awareness of colorectal cancer screening is increasing. Independently of this launch, Germany has recently updated its national screening program to ensure equal access for men and women starting at age 50, addressing prior gender-based discrepancies in risk assessment protocols. Research from the Institute for Quality and Efficiency in Health Care REIT (IQWiG) found no notable differences in recommended screening methods or intervals by gender, paving the way for unified practices. By simplifying the screening process and promoting equal access, the updated guidelines are expected to drive broader participation and enhance the integration of preventive measures in healthcare settings.

The collaborative launch underscores the shared dedication of Mainz Biomed and GANZIMMUN to advancing colorectal cancer diagnostics through cutting-edge innovation. This advancement empowers laboratory partners to offer a superior screening solution that aligns perfectly with current healthcare demands and trends during a pivotal time in the fight against CRC.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About GANZIMMUN Diagnostics

GANZIMMUN Diagnostics is one of the leading laboratories in Europe for preventive and complementary medicine. A multidisciplinary team comprising more than 420 employees processes approximately 5,500 laboratory orders per day under the leadership of the experienced laboratory physician, Dr. med. Patrik Zickgraf. The comprehensive diagnostic service spectrum, which includes over 4,000 laboratory parameters, includes besides the basic analytics a huge amount of innovative tests such as the ColoAlert.

To learn more, visit https://www.ganzimmun.de/en/

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 and the United Arab Emirates. The Company is currently running a pivotal FDA clinical 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 stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Anne Hennecke / Simone Neeten
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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 April 9, 2024. 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.