Mainz Biomed Announces Submission for FDA Breakthrough Device Designation for its Next Generation CRC Screening Test (Mainz Biomed)

Mainz Biomed has announced its submission for FDA Breakthrough Device Designation for its groundbreaking colorectal cancer (CRC) screening test. This next-generation test combines the Fecal Immunochemical Test (FIT) with advanced mRNA biomarkers and AI technology. Clinical trials demonstrated remarkable accuracy, with a 97% sensitivity for CRC and 88% for advanced adenomas. The non-invasive test offers a highly accurate alternative to traditional methods, potentially revolutionizing CRC diagnostics and reducing mortality rates.