NEW YORK — Mainz Biomed said on Friday that it has initiated a clinical study to evaluate the integration of mRNA biomarkers into its ColoAlert colorectal cancer test.
ColoAlert is a CE-marked PCR-based test designed to detect tumor DNA in stool samples. In January, Mainz acquired an exclusive option to license a collection of mRNAs from the Universite de Sherbrooke that have shown potential as biomarkers of curable precancerous colonic polyps and treatable early-stage colorectal cancer.
The planned clinical study, Mainz said, will evaluate the effectiveness of the biomarkers to expand ColoAlert's diagnostic profile to include the identification of advanced adenomas, which often give rise to colon cancer, increasing ColoAlert's rates of diagnostic sensitivity and specificity.
The trial is expected to include over 600 male and female patients ages 40 to 85 who have been referred for a colonoscopy. Colonoscopy findings will be compared with ColoAlert results to determine the sensitivity and specificity rates of ColoAlert with the added mRNA biomarkers. Secondary endpoints include sensitivity for advanced adenoma lesions in colon, specificity for advanced precancerous lesions in colon, and specificity for no colorectal finding.
Mainz said that it expects to begin patient enrollment in the second half of the year and report study results in early 2023. The German company added that results of the study are expected to impact its planned US Food and Drug Administration submission for ColoAlert.