Mainz Biomed has initiated a feasibility study as part of its PancAlert project, a research initiative developing a non-invasive, blood-based screening test for the early detection of pancreatic cancer.

The study aims to verify results from an earlier discovery-phase analysis conducted with Liquid Biosciences, which demonstrated 95% sensitivity and 98% specificity for detecting pancreatic cancer in blood samples.

Mainz Biomed, which specialises in molecular genetic diagnostics, will carry out the new phase in collaboration with Crown Bioscience, a global contract research organisation known for its expertise in translational research platforms and biomarker development. The study will assess the robustness, reproducibility, and diagnostic accuracy of a previously identified panel of mRNA biomarkers, along with a machine-learning algorithm designed to stratify blood samples by risk.

“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, chief executive officer at Mainz Biomed.

The feasibility stage will test the biomarker panel in real clinical samples under controlled laboratory conditions. Researchers will evaluate how reliably the assay performs, including its sensitivity and specificity, as well as how consistently the algorithm categorises the samples. The findings will determine whether the current panel and algorithm are suitable for advancement to a validation study.

Subject to successful feasibility outcomes, the company plans to conduct a larger validation study involving an expanded cohort of blood samples. This would be a crucial step toward optimising the test for clinical use and supporting potential regulatory submissions, including to the US Food and Drug Administration.

Pancreatic cancer is notoriously difficult to detect early, with most cases diagnosed at an advanced stage. The PancAlert project forms part of Mainz Biomed’s broader strategy to expand the reach of accessible molecular diagnostic tools in cancers where current screening methods are limited or non-existent.