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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.
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.
Posted In: MYNZ
