BERKELEY, US and MAINZ, Germany: Mainz Biomed (NASDAQ: MYNZ), a leading innovator in molecular genetics diagnostics, has announced the initiation of the feasibility stage for its PancAlert project – an ambitious effort to create a non-invasive, blood-based screening test for the early detection of pancreatic cancer.
The PancAlert feasibility study is designed to validate compelling results from a discovery phase completed earlier this year in partnership with Liquid Biosciences, which demonstrated 95% sensitivity and 98% specificity for pancreatic cancer detection using mRNA biomarkers and AI-driven analytics.
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Mainz Biomed is collaborating with Crown Bioscience, a global contract research organization (CRO) known for its translational research expertise. This phase will test the selected biomarker panel and the accompanying machine learning algorithm across a controlled set of real clinical blood samples.
The goal is to evaluate the test’s diagnostic accuracy, robustness, and consistency, while also validating the algorithm’s ability to stratify risk in diverse samples.
“This feasibility stage is a pivotal milestone in our mission to revolutionize cancer diagnostics,” said Guido Baechler, CEO of Mainz Biomed. “Pancreatic cancer continues to present significant detection challenges, and we are determined to deliver a breakthrough solution with real-world impact.”
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PancAlert: Validation Study Planned
Following the PancAlert feasibility phase, Mainz Biomed plans to launch a larger validation study involving a broader patient cohort. This would be a critical step toward optimizing the test for clinical use and preparing for regulatory pathways, including a potential submission to the U.S. Food and Drug Administration (FDA).
The PancAlert initiative reflects Mainz Biomed’s broader strategic focus on developing accessible and accurate molecular diagnostic tools for cancers with unmet screening needs, reaffirming the company’s commitment to transforming early detection across oncology.
