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Analysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay

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dc.contributor.authorViale, Giuseppe
dc.contributor.authorPaterson, Jennifer
dc.contributor.authorBloch, Miriam
dc.contributor.authorCsathy, George
dc.contributor.authorAllen, David
dc.contributor.authorDell’Orto, Patrizia
dc.contributor.authorKjærsgaard, Gitte
dc.contributor.authorLevy, Yaron Y.
dc.contributor.authorTrøst Jørgensen, Jan
dc.date.accessioned2021-12-13T09:17:04Z
dc.date.available2021-12-13T09:17:04Z
dc.date.issued2016
dc.description.abstractThe human epidermal growth factor receptor 2 (HER2) is an important target for treatment of gastroesophageal cancer. Different slide-based assays are available for assessment of HER2 status. Overexpression of the HER2 protein is assessed by immunohistochemistry (IHC) whereas amplification of the HER2 gene is assessed by fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods. Here we report a summary of the validation data on HER2 IQFISH pharmDx™ (Dako Omnis), a newly developed assay for the automated staining platform Dako Omnis. This assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of less than 4 hours from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary cover method comparison, assessment of staining quality, observer-to-observer reproducibility as well as reproducibility within and between laboratories. Based on data from the different studies it was concluded that HER2 IQFISH pharmDx (Dako Omnis) is a reliable and robust assay, with high precision and at least comparable to the manual HER2 IQFISH pharmDx™ assay. The HER2 IQFISH pharmDx (Dako Omnis) assay is currently not commercially available outside the European Union.es
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dc.format.extent9es
dc.identifier.citationHistology and Histopathology, Vol.31, nº12, (2016)
dc.identifier.doiDOI: 10.14670/HH-11-759
dc.identifier.issn1699-5848
dc.identifier.issn0213-3911
dc.identifier.urihttp://hdl.handle.net/10201/114864
dc.languageenges
dc.publisherUniversidad de Murcia. Departamento de Biología Celular e Histologíaes
dc.relationSin financiación externa a la Universidades
dc.rightsinfo:eu-repo/semantics/openAccesses
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectHER2es
dc.subjectIQFISHes
dc.subjectGastric canceres
dc.subjectAutomationes
dc.subjectCompanion diagnostices
dc.subject.otherCDU::6 - Ciencias aplicadas::61 - Medicina::616 - Patología. Medicina clínica. Oncologíaes
dc.titleAnalysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assayes
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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Histology and histopathology Vol.31,nº 12 (2016)