Mainz Biomed provides Q1 update, path to FDA premarket approval

During the first quarter of 2025: Path to FDA premarket approval: The Company enrolled the first patient into its feasibility study eAArly DETECT 2, which evaluates the Mainz Biomed’s (MYNZ) next-generation colorectal cancer test, integrating a portfolio of proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test. The study is expected to include a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to prevention. The inclusion of the first patient keeps the Company on schedule to report top-line results by the end of 2025. Mainz Biomed signed a license and option agreement with Liquid Biosciences to access novel mRNA biomarkers for early detection of pancreatic cancer via blood test. Independent validation of the algorithm-biomarker combination showed 95% sensitivity and 98% specificity. Mainz Biomed announced that GANZIMMUN Diagnostics has officially launched the enhanced ColoAlert CRC screening test.