Mainz Biomed partners with OncoVanguard8 to launch ColoAlert® colorectal cancer screening in South America, starting in Peru.
Quiver AI Summary
Mainz Biomed N.V. has entered into a Memorandum of Understanding with OncoVanguard8 to bring its DNA-based colorectal cancer screening test, ColoAlert®, to South America, beginning in Peru. This collaboration is significant due to the high incidence of colorectal cancer in the region, with about 17,000 new cases annually in Peru, Colombia, and Ecuador combined, emphasizing the need for improved early detection strategies. The partnership aims to enhance screening participation and align with public health initiatives to reduce cancer mortality. The two companies are working on a final distribution agreement that is anticipated to be signed soon, outlining key terms and market strategies for the rollout.
Potential Positives
- Signing of a Memorandum of Understanding (MOU) with OncoVanguard8 to distribute the ColoAlert® colorectal cancer screening test in South America, starting with Peru.
- The collaboration addresses a significant health issue, as approximately 17,000 new cases of colorectal cancer are diagnosed each year in the initial launch markets of Peru, Colombia, and Ecuador.
- The rollout of a DNA-based CRC screening solution is expected to enhance early detection and align with national public health initiatives, potentially reducing CRC-related mortality.
- The MOU outlines a clear go-to-market strategy, paving the way for a final distribution agreement to be signed shortly, indicating positive commercial prospects for Mainz Biomed.
Potential Negatives
- Signing an MOU with OncoVanguard8 highlights potential dependency on external partnerships for market entry, which may indicate that Mainz Biomed lacks the resources or capability to expand independently.
- The acknowledgment of various risks and uncertainties associated with forward-looking statements may raise concerns among investors about the company's ability to achieve its projections and navigate challenges.
- The reliance on the success of the initial launch markets in Peru, Colombia, and Ecuador suggests a concentrated risk, as any underperformance in these markets could significantly impact overall business prospects.
FAQ
What is ColoAlert®?
ColoAlert® is a DNA-based colorectal cancer screening test developed by Mainz Biomed for early detection of CRC.
Which markets will ColoAlert® be introduced to?
The initial introduction of ColoAlert® will begin in Peru, followed by Colombia and Ecuador.
What is the goal of the Mainz Biomed and OncoVanguard8 collaboration?
The collaboration aims to enhance colorectal cancer screening and improve early detection rates in South America.
How many new colorectal cancer cases occur in the initial launch markets?
Approximately 17,000 new cases of colorectal cancer are diagnosed each year in Peru, Colombia, and Ecuador.
What other products does Mainz Biomed offer?
Mainz Biomed's product portfolio includes PancAlert, a pancreatic cancer screening test currently in early-stage development.
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.
$MYNZ Hedge Fund Activity
We have seen 4 institutional investors add shares of $MYNZ stock to their portfolio, and 6 decrease their positions in their most recent quarter.
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Full Release
BERKELEY, Calif. and MAINZ, Germany, Nov. 18, 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, today announced the signing of a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert ® , a DNA-based colorectal cancer (CRC) screening test, to South America, starting with Peru.
Colorectal cancer continues to represent one of the most prevalent yet largely preventable cancer types on a global scale. In the three initial launch markets Peru, Colombia and Ecuador alone, approximately 17,000 new cases are diagnosed each year, highlighting the pressing demand for effective early detection and preventive strategies. The rollout of a DNA-based CRC screening solution presents a significant step forward, with the potential to markedly raise screening participation, facilitate timely diagnosis, and align seamlessly with national public health initiatives aimed at reducing CRC-related mortality and enhancing long-term population health outcomes.
In their common MOU, Mainz Biomed and OncoVanguard8 have outlined core commercial, legal and regulatory terms as well as the go-to-market strategy for the initial territory to be part of a final distribution agreement aimed to be signed within the next weeks.
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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 2 clinical study in preparation for its 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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About OncoVanguard8
OncoVanguard8 is a company focused on identifying and implementing innovative healthcare solutions for Latin America, with a mission to bridge the technological gap in cancer prevention and early detection. Based in Lima, Peru, the company develops strategic partnerships with insurers, hospitals, and healthcare networks to introduce advanced diagnostic technologies and promote equitable access to innovation. Operating across Peru, Colombia, and Ecuador, OncoVanguard8 serves as a regional catalyst for integrating global oncology advancements into local healthcare systems.
For media inquiries as to Mainz Biomed:
MC Services AG
Maximilian Schur / Simone Neeten
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[email protected]
For investor inquiries, please contact [email protected]
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 and its mid-year report on Form 6-K filed on September 26, 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.
