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Last week, we reported on findings presented at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, BC.
To evaluate the clinical performance of the next-generation, multitarget stool DNA test (Cologuard, Exact Sciences), researchers conducted the BLUE-C study, which enrolled 26 758 participants scheduled for screening colonoscopy at 186 US sites between November 2019 and January 2023.
Participants provided stool samples for testing with next-generation Cologuard and fecal immunochemical test (FIT) prior to colonoscopy. Researchers categorized colonoscopy findings as colorectal cancer (CRC), advanced precancerous lesions (APL), no advanced neoplasia, and nonneoplastic or negative colonoscopy.
Of the enrolled population, 75.4% (mean age, 63 years; 53.2% women; 60.1% non-Hispanic white) had evaluable findings.
The newest iteration Cologaurd demonstrated 94% sensitivity for CRC at 91% specificity.
Results also showed that Cologaurd test surpassed FIT in detecting neoplasms (93.9% vs 67.3%) as well as APLs (43.4% vs 23.3%). Importantly, the next-generation test also showed higher sensitivity for high-grade dysplasia (75% vs 47%; P<.001), the most clinically significant form of APL.
“These findings suggest that, if FDA approved, the mt-sDNA test will be a valuable option in providing non-invasive colorectal cancer screening."
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