{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T20:13:24Z","timestamp":1789762404871,"version":"4.0.1"},"reference-count":26,"publisher":"BMJ","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Clin Pathol"],"accepted":{"date-parts":[[2025,8,24]]},"abstract":"<jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>\n                     <jats:italic>HER2\/neu<\/jats:italic> gene is amplified in 15%\u201320% of invasive breast cancers (IBCs), serving as critical prognostic and predictive marker. <jats:italic>HER2<\/jats:italic>-targeted therapies have improved outcomes for <jats:italic>HER2<\/jats:italic>-positive patients, highlighting the importance of accurate assessment. Immunohistochemistry is commonly used for screening <jats:italic>HER2<\/jats:italic> overexpression, with equivocal cases reflex tested using in situ hybridisation (ISH) methods like fluorescence (FISH) or dual-colour dual ISH (D-DISH). While FISH displays quantitative accuracy, it is expensive, time-consuming and technically demanding. D-DISH offers a faster, automated alternative using bright-field microscopy for easier interpretation and better archiving. Advances in digital pathology, such as whole slide imaging and automated image analysis (IA), promise to improve <jats:italic>HER2<\/jats:italic> evaluation. The CE-IVD marked uPath HER2 Dual ISH IA algorithm by Ventana Medical Systems (Tucson, Arizona, USA) is designed to assist in this process, providing computer-assisted evaluation of <jats:italic>HER2\/neu<\/jats:italic>. Thus, we undertook this study to standardise and validate uPath Dual ISH IA algorithm and assess interobserver reproducibility in interpreting D-DISH assay.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This study retrospectively analysed 106 IBC cases, evaluating the concordance between manual and algorithm-assisted D-DISH evaluations.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>A consensus concordance rate of 91.5% and a Cohen\u2019s kappa value of 0.83 was observed between the manual and on-site IA evaluations, indicating near-perfect agreement. Remote IA evaluations also demonstrated substantial concordance, with a concordance rate of 88.89% and kappa value of 0.70.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>We successfully validated the uPath IA algorithm as a time-efficient, screening modality as well as viable alternative to manual interpretation for both on-site and remote interpretation of <jats:italic>HER2<\/jats:italic> D-DISH in a high-volume centre.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jcp-2025-210220","type":"journal-article","created":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T17:25:51Z","timestamp":1757352351000},"page":"jcp-2025-210220","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Validation of uPath HER2 dual-colour dual in-situ hybridisation image analysis tool for HER2\/neu testing in breast 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M","family":"Shet","sequence":"additional","affiliation":[{"name":"Department of Pathology, Tata Memorial Center, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trupti","family":"Pai","sequence":"additional","affiliation":[{"name":"Department of Pathology, Tata Memorial Center, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asawari","family":"Patil","sequence":"additional","affiliation":[{"name":"Department of Pathology, Tata Memorial Center, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sangeeta B","family":"Desai","sequence":"additional","affiliation":[{"name":"Department of Pathology, Tata Memorial Center, Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, 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