Mainz Biomed's First Quarter 2025 Update and FDA Approval Progress

Mainz Biomed N.V., a molecular genetics diagnostic company, has released its first quarter 2025 corporate update, highlighting significant developments and its path toward FDA premarket approval. The firm enrolled its first patient in a feasibility study for their next-generation colorectal cancer (CRC) test, eAArly DETECT 2, integrating mRNA biomarkers, an AI algorithm, and a FIT test. The study aims to include 2,000 participants, with results expected by the end of 2025.

They have also partnered with Liquid Biosciences to leverage mRNA biomarkers for early pancreatic cancer detection, showing high sensitivity and specificity. Additionally, their strategic alliance with labor team w ag in Switzerland introduces the DNA-based ColoAlert® CRC screening test to this new market. Mainz Biomed has also launched an updated version of ColoAlert in Germany with GANZIMMUN Diagnostics.

Furthermore, Mainz Biomed has met Nasdaq's compliance requirements, ensuring its continued listing. CEO Guido Baechler expressed satisfaction with the company's progress, emphasizing the eAArly DETECT 2 study's pivotal role in advancing US FDA approval plans.