Quest Diagnostics and Mainz Biomed Partner to Advance Colorectal Cancer Screening in the U.S.

In a significant development for cancer screening in the United States, Mainz Biomed N.V. (NASDAQ: MYNZ) has entered into a strategic partnership with Quest Diagnostics (NYSE: DGX) to advance the commercialization of ColoAlert, an innovative early detection test for colorectal cancer. This collaboration marks a crucial step towards making advanced cancer screening more accessible to millions of Americans at risk of colorectal cancer.

Under the agreement, Quest Diagnostics will provide clinical trial and laboratory services to support Mainz Biomed's ReconAAsense Food and Drug Administration (FDA) pivotal study of ColoAlert. The clinical trial, set to begin next year, is expected to involve up to 15,000 patients. This large-scale study is critical for obtaining FDA approval, which would allow ColoAlert to enter the U.S. market and potentially revolutionize colorectal cancer screening practices.

The partnership extends beyond the clinical trial phase. Quest Diagnostics has secured a semi-exclusive right to market ColoAlert in the U.S. for an eighteen-month period, should the product receive FDA approval. This agreement could significantly accelerate the adoption of ColoAlert across various healthcare channels, including physicians, health systems, hospitals, health plans, employers, and consumers.

ColoAlert's potential impact on public health cannot be overstated. Colorectal cancer is the third most common cancer globally, with over 1.9 million new cases reported in 2020. In the United States, despite recommendations for regular screening starting at age 45, approximately one-third of residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4 billion market opportunity and, more importantly, a critical area for improving health outcomes.

What sets ColoAlert apart is its ability to detect both bleeding and non-bleeding tumors through tumor DNA analysis. The test examines samples for four tumor markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA, and occult blood. Recent trials have shown promising results, with ColoAlert demonstrating sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. These high detection rates, especially for advanced adenomas, are crucial for early intervention and cancer prevention.

The collaboration between Mainz Biomed and Quest Diagnostics is part of a broader strategy to establish scalable distribution in the U.S. through partnerships with regional and national laboratory service providers. This approach, combined with Quest Diagnostics' extensive network of laboratories and patient service centers, could significantly enhance the accessibility and efficiency of colorectal cancer screening across the country.

The potential impact of this partnership extends beyond individual health outcomes. By improving early detection rates, ColoAlert could contribute to reducing the overall burden of colorectal cancer on the healthcare system. Early detection not only increases survival rates but also reduces the cost and complexity of treatment, potentially leading to significant savings in healthcare expenditure.

As Mainz Biomed prepares for the pivotal FDA study in 2025, the healthcare industry and patients alike will be watching closely. If successful, this collaboration could mark the beginning of a new era in cancer screening, one characterized by increased accessibility, improved accuracy, and ultimately, better health outcomes for millions of Americans at risk of colorectal cancer.