- 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 Design
- ColoFuture 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 across 21 sites in the U.S. with a similar design to that of ColoFuture, its European counterpart. Patients aged 45 years and older were invited to participate when referred for a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Those who agreed to provide a stool sample in advance of the colonoscopy (or treatment in the case of subjects with already identified colorectal cancer) were eligible for participation. Subjects were classified into groups following central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the ColoAlert® test incorporating the novel biomarkers.
The results from eAArly DETECT not only confirm but even surpass the good results from ColoFuture earlier this year that reported sensitivity for colorectal cancer of 94% with specificity of 97% and advanced adenoma sensitivity of 80%.
