Mainz Biomed Initiates Feasibility Study of Biomarker Panel in Pancreatic Cancer Project
- Early discovery analysis showed exceptional results with 95% sensitivity and 98% specificity for pancreatic cancer detection
- Partnership with established CRO Crown Bioscience for verification process enhances credibility
- Successful development could address a major unmet need in early pancreatic cancer detection
- Project could lead to FDA submission if validation is successful
- Results from feasibility study still pending and may not match initial discovery analysis
- Multiple development phases still required before potential commercialization
- No guarantee of successful FDA approval even if validation succeeds
Insights
Mainz Biomed's pancreatic cancer screening test shows promising early results as it advances to feasibility testing with impressive sensitivity/specificity metrics.
Mainz Biomed's advancement of their PancAlert project represents a potentially significant development in pancreatic cancer diagnostics. The company is now entering the feasibility phase after impressive discovery results showing
The technical approach combining mRNA biomarkers with machine learning algorithms is particularly noteworthy. Blood-based biomarker testing represents the cutting edge of cancer diagnostics, potentially offering significant advantages over traditional methods. For pancreatic cancer specifically, where early detection is challenging but critical for survival, a blood test with these performance characteristics could be transformative.
Collaboration with Crown Bioscience, an established CRO with expertise in translational platforms, adds credibility to this next phase. The feasibility study will assess critical parameters including robustness, reproducibility, and diagnostic performance - all essential validation steps before clinical implementation.
This represents a logical progression in diagnostic development: discovery phase completed, now moving to verification in clinical samples, with future validation studies planned pending results. The systematic approach aligns with standard regulatory pathways, suggesting Mainz is building toward potential FDA submission if results remain promising.
Pancreatic cancer remains one of oncology's most challenging diseases, with poor survival rates largely due to late diagnosis. A reliable early detection method would address a significant unmet medical need and could substantially impact patient outcomes.
Study is Intended to Verify Previous Discovery Results Demonstrating Sensitivity of
BERKELEY, Calif. and MAINZ, Germany, June 10, 2025 (GLOBE NEWSWIRE) -- 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
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 www.crownbio.com
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 mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
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