This story has been corrected to note that the firm's test is stool-based, and that the study is assessing a second-generation version of the assay.
NEW YORK – Molecular diagnostics firm Mainz Biomed said Thursday that it has begun enrollment for its eAArly DETECT 2 study, intended to further assess the company's next-generation RNA-based test for noninvasive detection of colorectal cancer.
The new version of Mainz's assay, branded ColoAlert, couples the detection of five mRNA biomarkers with fecal immunohistochemistry testing. The new study aims to recruit approximately 2,000 average-risk patients to validate previous results from smaller trials.
The German company said it expects to complete enrollment in the second half of 2025 and to report top-line results by the end of the year. Based on the outcome, Mainz will then finalize its protocols for a study in the US, called ReconAAsense, which it plans to begin in 2026.
In prior data, the company's approach has shown high sensitivity for both cancerous lesions and precancers.
"By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates," Mainz CEO Guido Baechler said in a statement.