Publication date: Jun 10, 2025

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. 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. 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%. 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.

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