Mainz Biomed and OncoVanguard8 Enter into Agreement to bring ColoAlert to South America
Rhea-AI Summary
Mainz Biomed (NASDAQ:MYNZ) signed a Memorandum of Understanding with OncoVanguard8 to introduce ColoAlert, a DNA-based colorectal cancer screening test, to South America beginning with Peru. The MOU outlines core commercial, legal and regulatory terms and a go-to-market strategy for an initial territory, with a final distribution agreement targeted within weeks.
The companies identified Peru, Colombia and Ecuador as initial launch markets, where about 17,000 new colorectal cancer cases are diagnosed annually, highlighting demand for early-detection screening solutions that could raise participation and support public health goals.
Positive
- MOU signed to commercialize ColoAlert in South America
- Target launch markets: Peru, Colombia, Ecuador
- 17,000 estimated annual CRC cases in initial markets
Negative
- None.
News Market Reaction
On the day this news was published, MYNZ declined 4.76%, reflecting a moderate negative market reaction. Argus tracked a peak move of +14.4% during that session. Argus tracked a trough of -22.7% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $341K from the company's valuation, bringing the market cap to $7M at that time. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
OncoVanguard8 is a leading service provider for innovative healthcare products for insurance companies operating in Peru, Colombia and Ecuador
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 mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook..
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
+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 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.
FAQ
What did Mainz Biomed announce on November 18, 2025 about ColoAlert (MYNZ)?
Which countries will Mainz Biomed (MYNZ) target first with ColoAlert?
How many colorectal cancer cases are estimated annually in the initial MYNZ target markets?
Does the November 18, 2025 announcement create a binding distribution agreement for MYNZ?
How might the ColoAlert rollout affect screening participation in MYNZ target markets?
