Mainz Biomed N.V. has announced a partnership with Quest Diagnostics to support the FDA pivotal study and potential commercialization of its colorectal cancer screening test, ColoAlert, in the United States. Under the agreements, Quest Diagnostics will provide clinical trial and laboratory services for the ReconAAsense study, which is scheduled to begin next year and involve up to 15,000 patients. This collaboration is crucial for Mainz Biomed's strategy to establish scalable distribution in the U.S. through partnerships with regional and national laboratory service providers.
The partnership addresses a critical need in cancer screening, as colorectal cancer is the third most common cancer globally, with over 1.9 million new cases reported in 2020. Currently, 71% of colorectal cancer diagnoses are made in later stages, despite a 90% five-year survival rate when detected early. ColoAlert offers a promising solution by analyzing tumor DNA for four markers associated with cancer: KRAS-mutation, BRAF-mutation, total amount of human DNA, and occult blood. The test can detect 85% of colorectal cancer cases, often in very early stages, with recent trials showing sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas.
The U.S. market represents a significant opportunity, with 16.6 million colonoscopies performed annually and about one-third of U.S. residents aged 50-75 having never been screened for colon cancer. Mainz Biomed estimates a $4 billion total market opportunity in the country. Quest Diagnostics' involvement extends beyond the clinical trial, as the company has been granted a semi-exclusive right to market ColoAlert in the U.S. for an eighteen-month period. If exercised, this option would allow Quest Diagnostics to offer the product through multiple channels, including physicians, health systems, hospitals, health plans, employers, and consumers.
Guido Baechler, Chief Executive Officer of Mainz Biomed, stated that teaming with Quest Diagnostics during the critical FDA study will be key to long-term success. This partnership follows Mainz Biomed's recent strategic alliance with Thermo Fisher Scientific, further strengthening the company's position in the U.S. market. With $8 million in funding dedicated to expediting FDA approval, Mainz Biomed is positioned to potentially transform cancer prevention in the United States.
The introduction of ColoAlert to the U.S. market could significantly impact public health outcomes by providing a less invasive and easy-to-use alternative to current screening methods. This may increase screening rates and lead to earlier detection of colorectal cancer, potentially improving survival rates and reducing the overall burden of the disease on the healthcare system. As Mainz Biomed progresses toward commercialization, the success of this venture could benefit both companies while potentially saving lives through improved early detection.
