Mainz Biomed Initiates Feasibility Study of Biomarker Panel in Pancreatic Cancer Project
Study is Intended to Verify Previous Discovery Results Demonstrating Sensitivity of 95% and Specificity of 98%
BERKELEY, Calif. and MAINZ, Germany, June 10, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces the commencement of the next phase in its PancAlert project, a research initiative focused on developing a non-invasive blood-based screening test for the early detection of pancreatic cancer. The feasibility phase is intended to confirm the discovery analysis performed in early 2025 in partnership with Liquid Biosciences which demonstrated sensitivity of 95% with specificity of 98% for the detection of pancreatic cancer in blood samples.
Having previously identified a panel of candidate mRNA biomarkers with potential clinical relevance, Mainz Biomed will now begin the verification process in collaboration with Crown Bioscience, a global contract research organization (CRO) known for its expertise in translational platforms that support drug discovery and development. The company provides preclinical and clinical research services to support biomarker development, enabling more accurate, predictive, and personalized medicine.
The feasibility stage involves testing the selected biomarkers and the accompanying ML-based algorithm in real clinical blood samples. The primary aim of this step is to evaluate the robustness, reproducibility, and diagnostic performance of the assay under controlled laboratory conditions using a predefined sample set. Feasibility will include assessing the assay’s sensitivity, specificity, and consistency, alongside evaluating the algorithm’s ability to accurately stratify samples based on risk. The data obtained will help determine the suitability of the current panel and algorithm for further development.
“We are excited to take this important next step in our PancAlert project. Early detection of pancreatic cancer remains one of the greatest unmet needs in oncology, and we are committed to delivering a solution that can significantly improve patient outcomes,” said Guido Baechler, CEO at Mainz Biomed.
Subject to the outcome of the feasibility phase, Mainz Biomed intends to proceed with a validation study using a larger cohort of blood samples. This would be a critical step toward optimizing the test for potential clinical utility and preparing it for future regulatory considerations, including a possible submission to the U.S. Food and Drug Administration (FDA). The pancreatic cancer project is part of the company’s broader strategy to develop accessible molecular diagnostics for early cancer detection, particularly in indications where current screening tools are limited or non-existent.
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About Crown Bioscience
Crown Bioscience is a CRO specializing in oncology and immuno-oncology, offers preclinical research, translational platforms, and clinical trial support to biotech and pharmaceutical companies to drive drug development and discovery. It provides unique tumor organoid models and the world's largest commercially available PDX collection, along with advanced laboratory services and an extensive biobank of liquid and human biospecimens across 11 global facilities. To learn more, visit
About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit or follow us on , and .
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