Mainz Biomed N. V. develops and markets in vitro diagnostic tests aimed at the early detection of cancer, with a primary focus on colorectal cancer screening, and pancreatic cancer screening. The company’s flagship product ColoAlert is a CE IVD certified multitarget stool test that combines a fecal immunochemical test, and PCR analysis of specific KRAS, and BRAF gene mutations to detect colorectal cancer, and advanced adenomas. Historically Mainz Biomed licensed the ColoAlert test from ColoAlert AS before acquiring the assay, and associated intellectual property in February 2023, after which it began manufacturing the test at its facility in Mainz Germany. In parallel the firm has been advancing a next generation colorectal cancer screening assay that integrates mRNA biomarkers sourced from the Université de Sherbrooke, and a fecal immunochemical test to improve detection of precancerous lesions. The firm has also secured an exclusive license from Liquid Bioscience to develop a blood based pancreatic cancer test using a panel of mRNA biomarkers, and a proprietary AI driven algorithm, and it is simultaneously working on a stool based pancreatic cancer candidate called PancAlert. These activities reflect the company’s strategy of applying cutting edge genetic diagnostic technologies to enable earlier, and more accurate cancer detection.

Mainz Biomed N. V. generates revenue principally through the sale of its ColoAlert colorectal cancer test to laboratories across Europe, which provides a recurring stream of product sales. The company also receives nonrefundable government grants that are applied toward the research, and development expenses of its PancAlert stool based pancreatic cancer test. Furthermore the licensing agreement with Liquid Bioscience includes an upfront fee of $1.2 million that the company is paying in installments through May 1, 2026, with the obligation to pay a royalty on future revenues should the option to acquire the biomarker portfolio be exercised. In addition Mainz Biomed has pursued occasional monetization of intellectual property, such as the March 2026 sale of the ColoAlert asset package, which yielded a reduction in an outstanding note, and resulted in the transfer of the test’s intellectual property inventory, and consumables to Uni Targeting Research AS.

Mainz Biomed N. V. positions itself as a provider of high sensitivity noninvasive cancer screening tests, competing with established colorectal screening products such as Exact Sciences Cologuard, and emerging liquid biopsy assays for pancreatic cancer; its competitive advantages include proprietary mRNA biomarker panels, AI driven algorithms, and CE IVD certification for its ColoAlert offering. The company’s ColoAlert test demonstrated a sensitivity of 85%, and a specificity of 92% in an independent clinical study conducted at the University Hospitals of Leipzig, and Halle Wittenberg, and subsequent upgrades have further improved its analytical performance. Its next generation colorectal cancer assay combines mRNA biomarkers, and a fecal immunochemical test, achieving sensitivities of up to 97% for colorectal cancer, and 82% for advanced adenomas in combined European and US clinical studies, which included 662 participants in the ColoFuture trial across Europe, and 254 subjects in the eAArly DETECT trial at 21 sites in the United States, for a total of 690 clinical specimens from 30 specialized gastroenterology centers. For pancreatic cancer the licensed mRNA biomarker panel coupled with the AI driven algorithm has shown a sensitivity of 95%, and a specificity of 98% in validation studies, suggesting a potential advantage over existing imaging, and biomarker based approaches. Mainz Biomed’s strategy emphasizes the use of proprietary genetic markers, and algorithmic analysis to deliver tests that are both accurate, and easy to administer using stool or blood samples.

The company serves clinical laboratories, and hospitals throughout Europe, with ColoAlert currently distributed to labs in multiple countries including Germany, France, Italy, Spain, and the United Kingdom. Clinical validation studies have involved the University Hospitals of Leipzig, and Halle Wittenberg in Germany, as well as a network of gastroenterology centers across Europe, and the United States that participated in the ColoFuture, and eAArly DETECT trials. Mainz Biomed also collaborates with the Université de Sherbrooke for access to mRNA biomarker libraries, and works closely with Liquid Bioscience on the development of its blood based pancreatic cancer test. These relationships underscore a customer base comprised of diagnostic laboratories, academic medical centers, and research partners that utilize the company’s screening assays for both routine screening, and investigative purposes.