The eAArly DETECT trial has revealed significant findings in the field of colorectal cancer (CRC) detection. Mainz Biomed’s novel mRNA biomarkers demonstrated a high sensitivity and specificity of 97% for CRC detection and an 82% sensitivity for advanced adenomas detection. These results not only confirm but also surpass the outcomes of the ColoFuture trial, which reported a 94% sensitivity for CRC and 80% sensitivity for advanced adenoma detection.
Key aspects of the eAArly DETECT trial include:
- The trial’s findings support the inclusion of these biomarkers in the next generation of Mainz Biomed’s ColoAlert CRC screening test.
- The mRNA biomarkers used in the trial were acquired from the University of Sherbrooke in Quebec, Canada, and were chosen for their potential to detect disease signals from patients with colorectal cancer and advanced adenomas.
- The eAArly DETECT trial, like the ColoFuture study, involved 254 patients aged 45 years or older who were referred for a colonoscopy. These patients provided stool samples before the colonoscopy for analysis.
- Guido Baechler, CEO of Mainz Biomed, highlighted the significance of these findings, stating that they represent a major advancement in CRC diagnostics and the potential for a self-administered screening tool with effective detection capabilities. The results from both the ColoFuture and eAArly DETECT trials support the use of the novel mRNA biomarkers in the upcoming ReconAAsense, a pivotal FDA premarket approval clinical trial set to begin enrollment in mid-2024.
Baechler expressed excitement about presenting the full dataset at a medical conference and preparing for the ReconAAsense trial, which aims to position the next generation ColoAlert as a robust and accurate at-home CRC diagnostic screening test.