Sara A DeNardis, Philip T Lavin, Jeff Livingston, William R Salter, Nanette James-Patrick, Emmanouil Papagiannakis, Christopher G Olson, Lori Weinberg

To validate, in US community-based colposcopy clinics, previous reports of increased detection of high-grade cervical intraepithelial neoplasia (CIN2+) with biopsies selected using dynamic spectral imaging (DSI) mapping after standard colposcopy. Cross-sectional observational study of 26 colposcopists across nine clinics recruiting consecutive colposcopy patients. Standard assessment with biopsy selections was completed before seeing the DSI map which was subsequently interpreted and used for additional biopsies per clinical judgment. Primary measure was the number of women with CIN2+ detected by DSI-assisted biopsies, over those detected by standard colposcopy biopsies. A total of 887 women were recruited. After exclusions, 881 women and 1,189 biopsies were analyzed. Standard biopsy detected 78 women with CIN2+ and DSI-assisted biopsies another 34, increasing the detection rate from 8.85% to 12.71% (p=0.00016). This was achieved with 16.16% of DSI-assisted biopsies finding CIN2+ compared to 13.24% for the preceding standard biopsies. For secondary specificity analysis, 431 women had only <CIN2 in standard biopsy/ies, a 48.92% rate, while 131 women who underwent no standard biopsy/ies had DSI-assisted biopsy/ies which were all <CIN2, a 35.22% rate (p<0.0001). The largest study, to date, of DSI used in colposcopy confirms previously reported increased detection of CIN2+, across multiple US community-based clinics. Based on the improved efficiency of the DSI-assisted biopsies, this increase suggests an improved diagnostic capacity achieved with DSI and cannot be explained solely by the taking of additional biopsies.