Multi-target stool DNA test: clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening.David H. Johnson, John B. Kisiel, Kelli N. Burger, Douglas W. Mahoney, Mary E. Devens, David A. Ahlquist, Seth Sweetser.     Gastrointest Endosc 2016 Nov 21.

AbstractBackground & Aims.Multi-target stool DNA testing (MT-sDNA) is now FDA-approved for average-risk CRC screening. Trials leading to its approval used blinded colonoscopy as the reference standard. In the post-approval screen setting, the clinical performance and impact of MT-sDNA on unblinded colonoscopy has not been described.

We measured the impact that knowledge of a positive MT-sDNA test result has on colonoscopy yield and quality.Methods.The unblinded group comprised all patients with positive MT-sDNA results on screening from 9/1/14-9/30/15 at a single tertiary center. Off-label test patients were excluded. The blinded group included all MT-sDNA positive participants in a pre-approval screening study from the same center. Detailed colonoscopy findings and withdrawal times were recorded.Results.There were 172 MT-sDNA positive patients in the unblinded group and 72 in the blinded group. More total adenomatous/sessile serrated polyps (70% vs 53%, p=0.013) and advanced neoplasms (28% vs 21%, p=0.27) were detected in unblinded than blinded groups. Median numbers of polyps detected were 2 (interquartile range, 1 - 4) and 1 (0 - 2) in unblinded and blinded groups, respectively (p=0.0007). Among polyps detected, flat or slightly raised lesions in the right colon were proportionately more frequent with unblinded (40%) than blinded examinasions (9%) (p=0.0017). Median withdrawal time was 19 min (13 – 29) in the unblinded group compared with 13 min (10 - 20) in the blinded group (p=0.0001).Conclusions.Knowledge of a positive MT-sDNA result appears to have a beneficial impact on the diagnostic yield and quality of subsequent colonoscopy. Leggi l'articolo


Additional information