Mainz Biomed Forms Agreement with Quest Diagnostics to Provide Clinical Trials Laboratory Services for Colorectal Cancer Screening Test

Core Insights - Mainz Biomed has entered into an agreement with Quest Diagnostics to support the commercialization of its NextGen colorectal cancer screening test, ColoAlert, pending FDA approval [1][3] - The ColoAlert test utilizes PCR technology to detect colorectal cancer tumor DNA from stool samples, demonstrating promising sensitivity and specificity in preliminary studies [2] - The collaboration includes Quest providing clinical trial laboratory services for Mainz Biomed's ReconAAsense study, which will involve approximately 15,000 subjects across 150 sites in the U.S. to gather data for FDA validation [3] Industry Context - Colorectal cancer is the third most common cancer globally, with over 1.9 million new cases reported in 2020, highlighting a significant public health concern [4] - The U.S. Preventive Services Task Force recommends screening for colorectal cancer starting at age 45, yet about one-third of U.S. residents aged 50-75 have never been screened, representing a market opportunity exceeding $4 billion [4] - The introduction of alternative screening methods like stool DNA-FIT tests could help address the screening gap in the population [4]