Mainz Biomed reports topline results from U.S. eAArly DETECT study

Mainz Biomed announced 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 biomarkers into a next generation version of ColoAlert, the Company’s screening test for colorectal cancer 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 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, 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 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%. The portfolio of mRNA biomarkers evaluated in the eAArly DETECT/ColoFuture studies was acquired from the Universite de Sherbrooke to potentially enhance ColoAlert’ s technical profile, further extending its capability to include the identification of advanced adenomas. In Sherbrooke’s pioneering work, researchers tested a battery of novel transcriptional mRNA biomarkers using samples obtained from patients diagnosed with CRC, or as having an advanced adenoma, and identified a subset of mRNA biomarkers that provided the greatest sensitivity and specificity of detection. Mainz Biomed specifically selected those mRNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with advanced adenomas. The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape. If advanced adenomas are identified early, they are curable. By treating the patient before the polyps can progress to a cancerous stage, CRC can be prevented.