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The sensitivity and specificity of both assays were assessed based on consensus IHC scores and amplification status, as determined by fluorescence in situ hybridization (FISH) according to 2018 ASCO\/CAP testing guidelines. There was a high concordance between results from the HercepTest (mAb) and PATHWAY 4B5 assays for HER2-negative (IHC 0, 1\u2009+\u2009, 2\u2009+\u2009and FISH negative) and HER2-positive (IHC 3\u2009+\u2009, 2\u2009+\u2009and FISH positive) breast carcinomas (98.2%). Regarding individual IHC scores, complete agreement was achieved in 69.7% (83\/119) of cases, and all but one of the discordant cases were due to higher HER2-status scoring using the HercepTest (mAb). Thus, more tumors were overscored as IHC 2\u2009+\u2009by HercepTest (mAb) (27 <jats:italic>versus<\/jats:italic> 15) as evidenced by their lower FISH positivity rate (48.1% <jats:italic>versus<\/jats:italic> 80%). However, two amplified tumors identified as IHC 2\u2009+\u2009by HercepTest (mAb) were missed by PATHWAY 4B5 (IHC 1\u2009+). Four additional cases identified as IHC 2\u2009+\u2009by HercepTest (mAb), with FISH ratio\u2009&lt;\u20092 but elevated gene counts (\u2265\u20094 to\u2009&lt;\u20096), were recorded negative by PATHWAY 4B5. The HercepTest (mAb) detects HER2 expression with higher sensitivity in tumors with gene amplification (ISH group 1) and increased gene counts (ISH group 4) as well as in HER2-low tumors (HER2 IHC2\u2009+\u2009\/FISH negative or IHC 1\u2009+). Future studies will demonstrate whether this translates into improved patient selection especially for new HER2-directed therapies.<\/jats:p>","DOI":"10.1007\/s00428-022-03378-5","type":"journal-article","created":{"date-parts":[[2022,8,16]],"date-time":"2022-08-16T02:02:36Z","timestamp":1660615356000},"page":"685-694","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":75,"title":["Comparison of HercepTest\u2122 mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2\/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status"],"prefix":"10.1007","volume":"481","author":[{"given":"Josef","family":"R\u00fcschoff","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Friedrich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Nagelmeier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthias","family":"Kirchner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lena M.","family":"Andresen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"Salomon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bryce","family":"Portier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone T.","family":"Sredni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans Ulrich","family":"Schildhaus","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bharat","family":"Jasani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marius","family":"Grzelinski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Viale","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,8,16]]},"reference":[{"key":"3378_CR1","unstructured":"Albagoush SA, Limaiem F, HER2 (2020)\u00a0In: StatPearls [Internet]. 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Ann Pathol. 41(6):507\u2013520. https:\/\/doi.org\/10.1016\/j.annpat.2021.07.014","journal-title":"Ann Pathol."}],"container-title":["Virchows Archiv"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00428-022-03378-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00428-022-03378-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00428-022-03378-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T16:12:45Z","timestamp":1667578365000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00428-022-03378-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,16]]},"references-count":39,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2022,11]]}},"alternative-id":["3378"],"URL":"https:\/\/doi.org\/10.1007\/s00428-022-03378-5","relation":{},"ISSN":["0945-6317","1432-2307"],"issn-type":[{"value":"0945-6317","type":"print"},{"value":"1432-2307","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,16]]},"assertion":[{"value":"31 March 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 June 2022","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 July 2022","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 August 2022","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"IVD-related diagnostic study is covered by an ethic approval to Agilent Technologies Inc., USA. All methods were performed in accordance with the relevant guidelines and regulations. Data were anonymized prior to use for the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"LMA and KS are employees and shareholders of Agilent Technologies Denmark Aps. BP and STS are employees and shareholders by Agilent Technologies Inc., USA. BJ and GV have acted as a consultant for Agilent Technologies Denmark Aps.Honoraria for lectures and advisory boards have been received by JR from MSD\/Merck, GSK, BMS, AstraZeneca, Roche, Exact Sciences, QuIP GmbH; HUS from MSD, BMS, Pfizer, Novartis Oncology, Roche Pharma, Molecular Health; GV from Roche, AstraZeneca, MSD, Pfizer, Novartis, Daiichi Sankyo.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}