Mainz Biomed Achieves 100% Sensitivity in Pancreatic Cancer Blood Test Feasibility Study
Key Insights
Mainz Biomed's feasibility study demonstrated 100% sensitivity and 95% specificity for pancreatic cancer (search) detection using a non-invasive blood-based screening test in a 30-subject cohort.
The company licensed proprietary mRNA biomarkers (search) from Liquid Biosciences (search) that achieved 95% sensitivity and 98% specificity in initial discovery studies across 285 subjects including 35 pancreatic cancer (search) patients.
The pancreatic cancer (search) project received public funding from Germany's ISB development bank, covering up to 50% of total project costs under their Innovation and Technology Support Program.
Mainz Biomed N.V. (NASDAQ:MYNZ) announced positive topline results from its feasibility study examining a non-invasive blood-based screening test for early detection of pancreatic cancer (search). The study achieved 100% sensitivity and 95% specificity in successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort that reflected different stages of the disease as well as precursors.
The molecular genetics diagnostic company evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity, with the leading panel delivering the breakthrough results. This performance builds on earlier discovery work conducted through Mainz Biomed's partnership with Liquid Biosciences (search).
Biomarker Discovery and Licensing Partnership
In March 2025, Mainz Biomed entered into a License and Option Agreement with Liquid Biosciences (search) to access a portfolio of novel mRNA biomarkers (search) for non-invasive pancreatic cancer (search) detection. The discovery process included multiple independent pancreatic cancer study cohorts, with Liquid using their proprietary EMERGE platform to identify clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients.
In the initial analysis, the biomarkers coupled with Liquid's proprietary algorithm achieved overall sensitivity of 95% and 98% specificity for pancreatic cancer (search) detection. According to Mainz Biomed, if these statistical results prove replicable after integration into a new product, the test has the potential to position the company's screening solution as "the most robust and accurate screening test for pancreatic cancer on the market."
Government Funding Support
The pancreatic cancer (search) project received significant validation through public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB's Innovation and Technology Support Program, the state will fund up to 50% of the project's total costs. Mainz Biomed characterized this direct governmental support as "a strong endorsement of the scientific and societal value" of their non-invasive, blood-based screening test.
Colorectal Cancer Program Expansion
While advancing its pancreatic cancer (search) pipeline, Mainz Biomed continued expanding its flagship ColoAlert (search) colorectal cancer (search) screening test across multiple markets. The DNA-based test received official registration with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and approval from Swissmedic, Switzerland's regulatory authority for medicinal products and medical devices.
The company launched eAArly DETECT 2, a US feasibility study evaluating its next generation colorectal cancer (search) test over approximately 2,000 average-risk patients. This study integrates proprietary mRNA biomarkers (search), AI-developed algorithms, and FIT testing to validate previous feasibility study results in preparation for the ReconAAsense US FDA pivotal trial.
Strategic Partnerships and Market Access
Mainz Biomed signed a Memorandum of Understanding with OncoVanguard8 (search) to introduce ColoAlert (search) to South America, starting with Peru. The collaboration targets markets where Peru, Colombia, and Ecuador alone diagnose approximately 17,000 new colorectal cancer (search) cases annually, highlighting significant demand for effective early detection strategies.
Additional partnerships include collaborations with labor team w ag in Switzerland, CARE diagnostica Laborreagenzien GmbH in Germany, and DoctorBox, a leading German digital health pioneer. These partnerships expand ColoAlert (search)'s reach across European markets and integrate the test into existing healthcare screening programs.
Clinical Development Timeline
CEO Guido Baechler commented on the company's progress: "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 (search) screening program."
Looking ahead, Mainz Biomed expects to complete its eAArly DETECT 2 feasibility study in the first half of 2026, which will serve as the launching point for the ReconAAsense US FDA pivotal colorectal cancer (search) study. The company also plans to announce next steps in advancing its blood-based pancreatic cancer (search) screening test during the same timeframe.