Mainz Biomed Provides Review of 2025 Highlights

Core Insights - Mainz Biomed N.V. has initiated the eAArly DETECT 2 clinical study to evaluate its next-generation colorectal cancer test, which integrates proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients [1][4] - The company reported a 100% sensitivity and 95% specificity in a feasibility study for a non-invasive blood-based screening test for pancreatic cancer, utilizing a panel of biomarkers licensed from Liquid Biosciences [3][8] - Mainz Biomed's ColoAlert® test has received regulatory approvals in the UK and Switzerland, marking significant milestones in its market expansion efforts [4][6] Colorectal Cancer Business Highlights - The eAArly DETECT 2 study aims to validate previous results and is a precursor to the upcoming ReconAAsense US FDA pivotal study [5] - ColoAlert®, a DNA-based colorectal cancer screening test, has been officially registered with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and Swissmedic in Switzerland [4] - A strategic partnership with labor team w ag will introduce ColoAlert® to the Swiss market, while a Memorandum of Understanding with OncoVanguard8 aims to expand its reach into South America, starting with Peru [4] Pancreatic Cancer Business Highlights - In March 2025, Mainz Biomed entered a License and Option Agreement with Liquid Biosciences to develop a blood test for pancreatic cancer, achieving a sensitivity of 95% and specificity of 98% in initial studies [3] - The pancreatic cancer project has received public funding from the Investitions- und Strukturbank Rheinland-Pfalz, covering up to 50% of the project's total costs, which underscores the project's scientific and societal value [8] - The company is focused on advancing its blood-based screening test for pancreatic cancer, with expectations to announce further developments in 2026 [5]