Mainz Biomed Reports Topline Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project
Study Demonstrated a Sensitivity of 100% and Specificity of 95%
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier this year. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved 100% sensitivity and 95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors.
These findings are consistent with the strong performance previously demonstrated in discovery and validation datasets, which achieved 95% sensitivity and 98% specificity earlier this year. The reproducibility of these results further strengthens confidence in the robustness of the biomarker panel and its potential as the foundation of a reliable, non-invasive screening test.
Importantly, the algorithm developed by Liquid Biosciences not only distinguished pancreatic cancer from healthy controls but also successfully detected precancerous lesions that have the potential to develop into pancreatic cancer if left untreated. The ability to identify these lesions through a blood test opens the door to monitoring at-risk individuals, intervening earlier in the disease process, and ultimately reducing the incidence and mortality associated with pancreatic cancer.
“We are thrilled about the team’s progress in confirming the strong clinical results from our discovery study. What’s particularly exciting is that our algorithm and biomarker selection can identify neoplasms in blood. Delivering a blood-based test capable of detecting early stages of disease is a major step toward the early detection—and ultimately the elimination—of pancreatic cancer,” said Guido Baechler, CEO Mainz Biomed
Having confirmed the validity of a panel of candidate mRNA biomarkers with strong potential clinical relevance, Mainz Biomed will begin planning a larger clinical study to finalize biomarker selection using banked retrospective samples. This upcoming study will evaluate the biomarkers’ performance across different stages of pancreatic cancer and further investigate the ability to identify early various stages of cancer and pre-cancer, leveraging next-generation sequencing technologies.
Subject to the outcome of the larger confirmatory study, Mainz Biomed intends to proceed with a validation study using a larger cohort of blood samples using Polymerase Chain Reaction technology (PCR). 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 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. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA 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 blood and 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.
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