Roche Digital Pathology Dx whole slide imaging system is comparable to traditional microscopy for primary diagnosis in surgical pathology
Keith A. Wharton, Jim Ranger‐Moore, Hon Seng, Alexander D. Borowsky, Cynthia A. Behling, Nicolas G. Cacciabeve, Michael LaFriniere, Richard M. Feddersen, Crystal Williams, Drew E. Baldwin, Richard F. Louie, Lauren B. Murata, Cameron M Smith, Andrea Visoski, Mingfei Zhao, Shalini Singh, Tracie N Gardner · American Journal of Clinical Pathology · 2025
OBJECTIVE: We evaluated the clinical performance of Roche Digital Pathology Dx, a whole slide imaging (WSI) system, in 2 studies according to US Food and Drug Administration (FDA) and Digital Pathology Association criteria. METHODS: Precision was measured by pathologists identifying 23 histopathology features; accuracy was assessed by comparing diagnoses from 2047 clinical cases with those from manual microscopy, with exploratory analyses including subgroup-specific diagnostic discrepancy rates. RESULTS: Both studies met all predetermined primary endpoints. Precision between systems/sites was 89.3%; between days, 90.3%; and between readers, 90.1% (lower bound of 95% CI for each, ≥85%). The difference in accuracy between digital reads (DRs) and manual microscopy reads (MRs) vs reference sign-out diagnosis (SD), DRs - MRs, was -0.61% (lower bound of 95% CI, -1.59%), which was greater than the lower bound acceptance criterion (-4%). Mean case reading times were similar: 2.33 minutes (DRs) and 2.34 minutes (MRs). Review of breast, lung, bladder, kidney, and stomach case diagnoses did not identify DR modality-specific root causes for major diagnostic disagreements. Higher than expected disagreements in both modalities were traced to COVID-19 pandemic-related resource constraints, leading to challenging case adjudications and higher disagreement rates for longer SDs. Direct DR/MR adjudication supported this hypothesis, resulting in an intermodality disagreement rate of 4.77%; using SD as a "tiebreaker" reduced the overall DR disagreement rate to 2.97%. CONCLUSIONS: Roche Digital Pathology Dx is noninferior to manual microscopy for primary diagnosis in surgical pathology, with performance results similar to 5 distinct FDA-cleared WSI systems using different scanners.