Mainz Biomed begins the feasibility phase of its PancAlert project for non-invasive pancreatic cancer detection using blood samples.
Quiver AI Summary
Mainz Biomed N.V. has announced the next phase in its PancAlert project, which aims to develop a non-invasive blood test for early pancreatic cancer detection. Following a successful discovery analysis showing high sensitivity (95%) and specificity (98%) in partnership with Liquid Biosciences, the company will now verify candidate mRNA biomarkers with Crown Bioscience's help. This feasibility phase involves testing these biomarkers and a machine learning algorithm using real clinical samples to assess sensitivity, specificity, and overall diagnostic performance. The outcome will inform whether the project progresses to a larger validation study, potentially leading to FDA submission. CEO Guido Baechler highlighted the need for improved early detection methods in oncology, positioning this initiative as part of Mainz Biomed's broader goal to advance accessible molecular diagnostics for various cancers.
Potential Positives
- Mainz Biomed has commenced the next phase of its PancAlert project, aimed at developing a non-invasive blood test for early detection of pancreatic cancer, addressing a significant unmet need in oncology.
- The preliminary results from a partnership with Liquid Biosciences indicate a high sensitivity of 95% and specificity of 98%, showcasing the potential accuracy of the test in pancreatic cancer detection.
- The collaboration with Crown Bioscience for the verification process enhances the credibility and technical capabilities of the research initiative, as they are known for their expertise in supporting drug discovery and development.
- The successful completion of the feasibility phase could lead to a larger validation study and potential submission to the FDA, paving the way for regulatory approval and commercialization of a critical diagnostic tool.
Potential Negatives
- The release emphasizes a feasibility phase for the PancAlert project, signaling that the test is still in early development and not yet ready for market, which could raise concerns about delays in bringing effective solutions to pancreatic cancer detection.
- By linking the success of the project to numerous future studies and regulatory approvals, the company may be indicating potential risks and uncertainties that could negatively impact investor confidence and expectations.
- The mention of the ongoing effects of the COVID-19 pandemic implies that market conditions and operations may still be unstable, adding another layer of risk for stakeholders.
FAQ
What is the PancAlert project by Mainz Biomed?
The PancAlert project aims to develop a non-invasive blood test for early detection of pancreatic cancer.
What are the expected outcomes of the feasibility phase?
The feasibility phase will evaluate the assay's sensitivity, specificity, and consistency in detecting pancreatic cancer.
Who is collaborating with Mainz Biomed on this project?
Mainz Biomed is collaborating with Crown Bioscience, a CRO specializing in oncological diagnostics and biomarker development.
What is the significance of early pancreatic cancer detection?
Early detection of pancreatic cancer is crucial as it remains a significant unmet need in oncology, improving patient outcomes.
What regulatory steps will follow after the feasibility phase?
After feasibility, Mainz Biomed plans to conduct a validation study and potentially submit for FDA approval.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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 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
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
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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.
