Mainz Biomed Initiates Feasibility Study of Biomarker Panel in Pancreatic Cancer Project

Mainz Biomed Initiates Feasibility Study of Biomarker Panel in Pancreatic Cancer Project

Dil Bar Irshad | June 10, 2025 | 10:52 PM IST | Breaking News | Follow on Google News

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, US and MAINZ, Germany – June 10, 2025 — Mainz Biomed N.V. (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.

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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.

Dil Bar Irshad

Dil Bar Irshad is a seasoned journalist, hails from Jammu Kashmir's Doda, covers political, social, business stories, index stories.