A novel multitarget stool RNA test for colorectal cancer screening achieved a sensitivity of 94% for CRC and 46% for advanced adenomas and a specificity of 88% for no lesions on colonoscopy, according to data from the CRC-PREVENT trial.
“The test demonstrated high sensitivity and specificity across all age groups, with significant improvement in sensitivity for colorectal neoplasia when compared to a FIT [fecal immunochemical test],” said senior investigator David S. Lieberman, MD, a professor of medicine and former chief of gastroenterology at Oregon Health & Science University, in Portland. “The mt-sRNA test [Colosense, Geneoscopy] met its primary end points and is being considered for approval by the FDA.”
Of note, Dr. Lieberman said, the study included 45- to 49-year-olds—who now are included in CRC screening recommendations but for whom noninvasive screening test efficacy data are lacking. In this younger age bracket, which made up 24% of the study population, sensitivity for CRC was 100% and sensitivity for advanced adenomas was 44%.
“Maintenance of sensitivity in participants aged 45 to 49 was likely attributable to the use of RNA biomarkers, which are not subject to DNA age-related methylation patterns that may impact test results across age groups,” Dr. Lieberman said.