Mainz Biomed Announces Promising Results from Pancreatic Cancer Biomarker Study

Posted on by

The study showed a sensitivity of 100% and a specificity of 95%.

Mainz Biomed (NASDAQ:MYNZ), a molecular genetics diagnostics company focused on early cancer detection, has announced positive results from its feasibility study of a non-invasive, blood-based screening test for the early detection of pancreatic cancer. The study, which began earlier this year, confirmed the accuracy and utility of proprietary biomarkers licensed from Liquid Biosciences for developing a pancreatic cancer screening test. Researchers assessed 18 biomarkers across various panels to simplify the assay. The leading panel achieved 100% sensitivity and 95% specificity, successfully differentiating pancreatic cancer patients from healthy individuals in a group of 30 subjects, representing different stages of the disease and its precursors.

These results align with the strong performance previously observed in discovery and validation datasets, which demonstrated 95% sensitivity and 98% specificity earlier in the year. The consistency of these findings reinforces confidence in the biomarker panel’s reliability and its potential as the basis for a dependable, non-invasive screening test.

Notably, the algorithm developed by Liquid Biosciences not only distinguished pancreatic cancer from healthy controls but also identified precancerous lesions that could develop into pancreatic cancer if untreated. The ability to detect these lesions via a blood test allows for monitoring at-risk individuals, earlier intervention, and a potential reduction in the incidence and mortality of pancreatic cancer.

“We are excited about the team’s progress in confirming the strong clinical results from our discovery study. The fact that our algorithm and biomarker selection can identify neoplasms in blood is particularly encouraging. Delivering a blood-based test capable of detecting early stages of disease is a significant step toward the early detection—and ultimately the elimination—of pancreatic cancer,” stated Guido Baechler, CEO of Mainz Biomed.

Having confirmed the validity of a panel of candidate mRNA biomarkers with strong clinical potential, Mainz Biomed will now plan a larger clinical study to finalize biomarker selection using stored retrospective samples. This upcoming study will evaluate the biomarkers’ performance across different stages of pancreatic cancer and further investigate their ability to identify early stages of cancer and pre-cancer, using next-generation sequencing technologies.

Pending the results of the larger confirmatory study, Mainz Biomed intends to conduct a validation study using a larger set of blood samples and Polymerase Chain Reaction (PCR) technology. This would be a crucial step in optimizing the test for clinical use and preparing it for regulatory submissions, 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 readily available molecular diagnostics for early cancer detection, especially in areas where current screening methods are limited or absent.

Please follow us to stay up to date:

About Mainz Biomed NV
Mainz Biomed develops molecular genetic diagnostic solutions for life-threatening conditions that are ready for the market. The Company’s main product is ColoAlert®, an accurate, non-invasive, and user-friendly diagnostic test for the early detection of colorectal cancer. ColoAlert® is sold throughout Europe. The Company is currently conducting its eAArly DETECT 2 clinical study to prepare for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product pipeline also includes PancAlert, an early-stage screening test for pancreatic cancer based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. For more information, visit or follow us on , and .

For media inquiries
MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20

For investor inquiries, please contact

Forward-Looking Statements
Certain statements in this press release are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995’s “safe harbor” provisions. These statements can be identified by terms such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project,” as well as similar expressions that predict or indicate future events or trends, or that are not statements of historical fact. These forward-looking statements reflect the current analysis of existing information and are subject to risks and uncertainties. Therefore, caution should be taken when relying on them. Actual results may differ significantly from the Company’s expectations or projections due to known and unknown risks. Factors that could cause actual results to differ materially include: (i) failure to achieve projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the impact 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 discussed periodically in the Company’s other reports and public filings with the Securities and Exchange Commission (the “SEC”).

“`