Mainz Biomed N.V. announced a memorandum of understanding with OncoVanguard8, a Latin‑American oncology distribution firm, to launch its DNA‑based colorectal cancer screening test, ColoAlert, in Peru, Colombia, and Ecuador. The agreement targets the three countries where an estimated 17,000 new colorectal cancer cases are diagnosed each year, creating a sizable unmet need for non‑invasive screening solutions.
The deal marks Mainz Biomed’s first foray into the South American market, extending its presence beyond its existing European and United Arab Emirates operations. By partnering with OncoVanguard8, the company gains access to an established distribution network that can accelerate product penetration and generate a new revenue stream while demonstrating international market traction—an important factor for the company’s ongoing pursuit of U.S. FDA approval for its next‑generation screening platform.
OncoVanguard8 brings deep regional expertise, with a logistics and sales infrastructure that covers major urban centers in Peru, Colombia, and Ecuador. The firm has previously introduced other oncology diagnostics in the region, positioning it to support ColoAlert’s rollout through established relationships with hospitals, private clinics, and national health programs.
The Latin American colorectal cancer diagnostics market is projected to grow at a compound annual growth rate of 7.6% from 2024 to 2030, reaching an estimated USD 803.9 million in 2023. ColoAlert’s stool‑DNA test offers a convenient, non‑invasive alternative to colonoscopy, addressing a critical gap in screening uptake and aligning with regional health priorities that emphasize early detection.
Mainz Biomed has faced financial challenges in recent quarters, including a Nasdaq listing compliance issue that was resolved in early 2025 and a series of follow‑on offerings to strengthen its balance sheet. The company’s current financial position underscores the importance of new revenue opportunities, and the South American expansion is a key component of its strategy to diversify income and support future growth initiatives.
By securing a foothold in a high‑incidence region, Mainz Biomed can showcase the clinical and commercial viability of ColoAlert outside the United States, a factor that can positively influence the FDA’s assessment of the test’s safety and effectiveness. The partnership also positions the company to capture early‑stage colorectal cancer detection in a market with limited high‑accuracy options, potentially accelerating its path to broader commercialization and reinforcing its global footprint.
Overall, the MOU represents a significant strategic milestone for Mainz Biomed, combining market expansion, regulatory momentum, and financial diversification in a single transaction that aligns with the company’s long‑term growth objectives.
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