The ColoAlert test, developed by Mainz Biomed, is an at-home diagnostic tool designed to detect colorectal cancer early. While colonoscopies remain the primary method for detecting colorectal cancer, approximately 20% of U.S. adults aged 45 and older avoid this procedure. The ColoAlert test offers a convenient alternative, allowing patients to collect stool samples at home and mail them to a lab for analysis.
The test identifies tumor DNA in the stool samples using real-time PCR multiplex detection of molecular-genetic biomarkers, making it more sensitive than traditional stool tests. Preliminary studies in Europe have shown a sensitivity of 94% and specificity of 97% for colorectal cancer, and 81% sensitivity for advanced adenomas. The test is currently available in select European countries and is undergoing FDA clinical studies for U.S. approval, with a potential rollout in the U.S. market by 2026.