Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company, has outlined significant achievements from 2025, emphasizing advancements in cancer detection technologies. The company is known for its innovative approaches to early cancer detection, particularly with its colorectal and pancreatic cancer screening solutions. Year-end financial results are expected to be released in March 2026.
Key Developments in Colorectal Cancer Detection
In 2025, Mainz Biomed launched the eAArly DETECT 2 clinical study in the United States, focusing on its next-generation colorectal cancer (CRC) test. This feasibility study aims to validate results from previous studies involving approximately 2,000 average-risk patients. The study integrates proprietary mRNA biomarkers, an artificial intelligence (AI) developed algorithm, and a fecal immunochemical test (FIT).
The company’s flagship product, ColoAlert®, received registration from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and gained approval for marketing in Switzerland through Swissmedic. This positions ColoAlert® as a pioneering DNA-based CRC screening test in Switzerland, following a strategic partnership with the diagnostic laboratory labor team w ag in Goldach.
Additionally, Mainz Biomed entered a Memorandum of Understanding with OncoVanguard8 to distribute ColoAlert® in South America, beginning with Peru. Collaborations with CARE diagnostica Laborreagenzien GmbH also aim to expand screening services for risk groups, incorporating ColoAlert® in their offerings.
Pancreatic Cancer Innovations
In March 2025, Mainz Biomed secured a License and Option Agreement with Liquid Biosciences, gaining access to a portfolio of novel mRNA biomarkers for non-invasive pancreatic cancer detection via blood tests. This collaboration incorporates data from a cohort of 285 subjects, including 35 pancreatic cancer patients, yielding an impressive 95% sensitivity and 98% specificity for cancer detection.
The company reported promising topline results from a feasibility study that confirmed the clinical accuracy of these biomarkers. The study, which involved a panel of 18 licensed biomarkers, achieved 100% sensitivity and 95% specificity in a cohort of 30 subjects, effectively distinguishing pancreatic cancer patients from healthy controls.
Mainz Biomed’s pancreatic cancer project will benefit from support from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), which will fund up to 50% of the project’s costs under the Innovation and Technology Support Program. This governmental endorsement underscores the societal value of Mainz Biomed’s non-invasive testing solutions.
“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy,” stated Guido Baechler, Chief Executive Officer of Mainz Biomed. He noted that the completion of the eAArly DETECT 2 study will set the stage for pursuing U.S. FDA regulatory approval in 2026.
As Mainz Biomed continues to innovate in cancer diagnostics, its strategic partnerships and advancements in technology position it for significant growth in the global healthcare landscape. Further information can be found on the company’s official investor website at mainzbiomed.com/investors/.
