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

Mainz Biomed N.V. (NASDAQ: MYNZ) has announced a strategic partnership with Quest Diagnostics (NYSE: DGX) to advance the commercialization of ColoAlert, an early colorectal cancer detection screening test, in the United States. This collaboration marks a significant step towards addressing the critical need for improved cancer screening methods in one of the world's largest healthcare markets.

Under the agreement, Quest Diagnostics will provide clinical trial and laboratory services for Mainz Biomed's ReconAAsense Food and Drug Administration pivotal study of ColoAlert, scheduled to begin next year with up to 15,000 patients. Additionally, Quest has secured a semi-exclusive right to market ColoAlert in the U.S. for an eighteen-month period, potentially offering the product across multiple healthcare channels.

The partnership comes at a crucial time, as colorectal cancer remains the third most common cancer globally, with over 1.9 million new cases reported in 2020. Despite recommendations for regular screening starting at age 45, only about four in ten colorectal cancers are detected at an early stage in the United States. ColoAlert, which boasts a 90% sensitivity rate for detecting colorectal cancer and over 80% for advanced adenomas, could significantly improve these statistics.

Mainz Biomed's CEO, Guido Baechler, emphasized the importance of this collaboration, stating, "Teaming with Quest Diagnostics during our critical FDA Study will be key to our long-term success." The partnership not only supports the clinical trial but also paves the way for potential widespread distribution of ColoAlert, should it receive FDA approval.

The implications of this partnership extend beyond the immediate business prospects for Mainz Biomed and Quest Diagnostics. If successful, ColoAlert could transform the landscape of colorectal cancer screening in the United States. The test's high sensitivity, combined with its non-invasive nature and ease of use, could lead to increased screening rates and earlier detection of colorectal cancer, potentially saving numerous lives.

Moreover, this collaboration represents a significant step towards addressing the $4 billion market opportunity in the U.S., where approximately one-third of residents aged 50-75 have never been screened for colon cancer. The successful introduction of ColoAlert could not only capture a substantial portion of this market but also contribute to closing the critical gap in cancer screening practices.

As the healthcare industry continues to prioritize preventive care and early detection, partnerships like this one between Mainz Biomed and Quest Diagnostics are likely to play an increasingly important role in shaping the future of cancer diagnostics and patient care. The potential impact on public health outcomes and the broader healthcare economy makes this development one to watch closely in the coming years.