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Mainz Biomed Reports Positive Topline Results from U.S. eAArly DETECT Study Evaluating Novel mRNA Biomarkers
Groundbreaking Results Demonstrate Sensitivity for Colorectal Cancer of 97% with Specificity of 97% and Advanced Adenoma Sensitivity of 82%Results Exceed
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[{"type":"text","content":"Groundbreaking Results Demonstrate Sensitivity for Colorectal Cancer of 97% with Specificity of 97% and Advanced Adenoma Sensitivity of 82%Results Exceed those from the Company’s European ColoFuture Clinical Study of the Same DesignColoFuture and eAArly DETECT Studies Support Inclusion of a Portfolio of Novel mRNA Biomarkers in Pivotal FDA PMA Clinical Trial (ReconAAsense); Trial is On Track to Commence Enrollment in Mid-2024 BERKELEY, Calif. and MAINZ, Germany, Dec. 05, 2023 (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, announced today groundbreaking topline results from its eAArly DETECT U.S. clinical study, a multi-center feasibility study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into a next generation version of ColoAlert®, the Company’s highly efficacious and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories. The eAArly DETECT topline results reported a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. They confirm the positive results from ColoFuture, its European counterpart which reported data in October 2023. “The eAArly DETECT and ColoFuture study read-outs not only represent an outstanding result for the Company but also for CRC disease treatment and personal healthcare management. The results offer the unique promise of a self-administered screening tool with highly effective detection of adenomas (AA), a type of pre-cancerous polyp often attributed to this deadly disease,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Upgrading the technical configuration of our at-home CRC screening test to include AA diagnostic capability represents a major innovation in the field of CRC diagnostics. We are excited to present the full dataset at an upcoming medical conference and ramp-up preparations to commence patient enrollment in ReconAAsense, our pivotal FDA pre-market approval trial. If successful, this will position a next generation ColoAlert® as the most robust and accurate at-home CRC diagnostic screening test on the market.” The eAArly DETECT study enrolled 254 evaluable subjects a...