Core Insights - Mainz Biomed is advancing its FDA premarket approval study for its next-generation colorectal cancer screening product and has made a strategic acquisition in pancreatic cancer screening [1] - The company launched the eAArly DETECT 2 study, a US feasibility study involving approximately 2,000 average-risk patients to validate previous colorectal cancer test results [3] - A strategic partnership with labor team w ag introduces the ColoAlert® test to the Swiss market, marking Mainz Biomed's entry into Switzerland [3] - Mainz Biomed has partnered with EDX Medical Group to expand its molecular diagnostic technology in the UK [3] - A License and Option Agreement with Liquid Biosciences aims to develop a blood test for pancreatic cancer detection, showing a sensitivity of 95% and specificity of 98% based on a cohort of 285 subjects [3] - The PancAlert project is progressing with public funding from the Investitions- und Strukturbank Rheinland-Pfalz, covering up to 50% of the project's costs [3] - Mainz Biomed has regained compliance with Nasdaq listing requirements, ensuring continued trading on the Nasdaq Capital Market [3] - The company priced a follow-on offering of 2,000,000 units for gross proceeds of approximately $4.0 million, with each unit sold at an effective price of $2.00 [3] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product being the ColoAlert® test for colorectal cancer [5] - The company is conducting a pivotal FDA clinical study for US regulatory approval and is developing the PancAlert test for pancreatic cancer screening [5]

Company Overview - Mainz BioMed is developing a novel standard for non-invasive detection of advanced adenomas (AA)[8] - The company has a disruptive, decentralized business model[9] - Mainz BioMed launched its first-generation CRC screening test, ColoAlert®, in Europe[10] - The company possesses a strong intellectual property position[12] Market Opportunity and Product - The US annual market for colorectal cancer (CRC) screening is estimated to be > $30 billion by 2032[14] - ColoAlert® is a highly efficacious, at-home, stool-based screening test for early CRC detection, combining a FIT test with PCR results of specific tumor DNA markers[15] - ColoAlert® has high accuracy with 92% specificity and 85% sensitivity[25] - In a screening population >= 45, 21% sensitivity for adenomas would reduce mortality from CRC by 47%, and 76% sensitivity would reduce mortality from CRC by 67%[21] Partnerships and Financials - Mainz BioMed entered into a Collaboration Agreement with Thermo Fisher Scientific in November 2024, with Thermo Fisher providing resources and discounts on instrumentation[17] - Mainz BioMed also entered into Agreements with Quest Diagnostics in November 2024, with Quest becoming a lab partner for the pivotal study and having a semi-exclusive distributor option right in the U S[17] - For the year ended December 31, 2024, ColoAlert® revenue was $893,991, with a gross profit of $574,883[50]