Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company based in Mainz, Germany, has outlined its significant advancements for the year ending December 31, 2025. The company, known for its innovative cancer detection solutions, plans to release its year-end financial results in March 2026.
Highlights in Colorectal Cancer Initiatives
In 2025, Mainz Biomed launched the eAArly DETECT 2 study, a clinical feasibility project in the United States aimed at evaluating the performance of its next-generation colorectal cancer (CRC) test. This study focuses on approximately 2,000 average-risk patients and integrates proprietary mRNA biomarkers alongside an AI-developed algorithm and a fecal immunochemical test (FIT). The initiative is designed to validate earlier promising results from previous studies involving both average and identified-risk patients.
The company also achieved important regulatory milestones with its flagship product, ColoAlert®. In January 2026, ColoAlert® received official registration from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, allowing for its marketing in the region. Furthermore, the test has been registered and approved for distribution by Swissmedic, Switzerland’s regulatory authority for medicinal products and medical devices.
A strategic partnership was formed with labor team w ag, a prominent diagnostic laboratory in Goldach, Switzerland, marking the introduction of ColoAlert® into the Swiss market. Additionally, Mainz Biomed signed a Memorandum of Understanding with OncoVanguard8, aiming to distribute ColoAlert® in South America, starting with Peru.
The company is also collaborating with CARE diagnostica Laborreagenzien GmbH, which works with over 15 statutory health insurance companies on online screening concepts. This partnership may expand risk group services to include ColoAlert®, which utilizes molecular genetic analysis of stool biomarkers through PCR to enhance early disease detection rates.
Another significant milestone occurred with ColoAlert® being added to the portfolio of DoctorBox, a leading digital health platform in Germany. This step underscores Mainz Biomed’s commitment to expanding its European footprint and enhancing innovative preventive medicine solutions. Laboratory analyses will be conducted by the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.
Advancements in Pancreatic Cancer Detection
In March 2025, Mainz Biomed secured a License and Option Agreement with Liquid Biosciences to access a portfolio of novel mRNA biomarkers for a non-invasive blood test aimed at detecting pancreatic cancer. This collaboration involves developing a blood-based test for potential future applications to the U.S. Food and Drug Administration (FDA). The research utilized multiple independent pancreatic cancer study cohorts, identifying clinically relevant biomarkers through Liquid’s proprietary EMERGE platform.
The results from the analysis indicated a remarkable sensitivity of 95% and specificity of 98% for pancreatic cancer detection. If the findings are replicable in new product integration, Mainz Biomed could offer one of the most precise screening tests for pancreatic cancer available.
In October 2025, the company reported positive topline results from its feasibility study assessing the non-invasive blood-based test. This study confirmed the clinical accuracy of the proprietary biomarkers licensed from Liquid Biosciences. The leading panel evaluated 18 biomarkers across candidate panels, achieving 100% sensitivity and 95% specificity in distinguishing pancreatic cancer patients from healthy controls in a cohort of 30 subjects.
Moreover, the pancreatic cancer project has received public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), which will support up to 50% of the project’s total costs under its Innovation and Technology Support Program. This governmental backing emphasizes the scientific and societal value of Mainz Biomed’s non-invasive screening test for early pancreatic cancer detection.
“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy, driven by our eAArly DETECT 2 study and continued progress in our pancreatic cancer screening program,” stated Guido Baechler, Chief Executive Officer of Mainz Biomed. He added that the first half of 2026 will see the completion of the eAArly DETECT 2 feasibility study, serving as a precursor for the ReconAAsense pivotal colorectal cancer study in the U.S., alongside the announcement of further developments in the pancreatic cancer screening initiative.
For more information, investors can visit Mainz Biomed’s official website or follow the company on LinkedIn, X (formerly Twitter), and Facebook.
