{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T03:02:20Z","timestamp":1790996540387,"version":"4.1.0"},"reference-count":47,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2025,6,10]],"date-time":"2025-06-10T00:00:00Z","timestamp":1749513600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Roche Diagnostics International Ltd"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,9,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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,\u2005\u226585%). The difference in accuracy between digital reads (DRs) and manual microscopy reads (MRs) vs reference sign-out diagnosis (SD), DRs \u2013 MRs, was \u20130.61% (lower bound of 95% CI, \u20131.59%), which was greater than the lower bound acceptance criterion (\u20134%). 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 \u201ctiebreaker\u201d reduced the overall DR disagreement rate to 2.97%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ajcp\/aqaf052","type":"journal-article","created":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T08:01:29Z","timestamp":1745913689000},"page":"367-384","source":"Crossref","is-referenced-by-count":7,"title":["Roche Digital Pathology Dx whole slide imaging system is comparable to traditional microscopy for primary diagnosis in surgical pathology"],"prefix":"10.1093","volume":"164","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0374-1114","authenticated-orcid":false,"suffix":"Jr.","given":"Keith A","family":"Wharton","sequence":"first","affiliation":[{"name":"Roche Diagnostics Solutions , Oro Valley, AZ ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jim","family":"Ranger-Moore","sequence":"additional","affiliation":[{"name":"Roche Diagnostics Solutions , Oro Valley, AZ ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hon","family":"Seng","sequence":"additional","affiliation":[{"name":"Roche Diagnostics Solutions , Oro Valley, AZ ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander D","family":"Borowsky","sequence":"additional","affiliation":[{"name":"Department of Pathology, University of California Davis , Davis, CA ,","place":["United 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