Analysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2IQFISH pharmDx™ (Dako omnis) assay

Giuseppe Viale, Jennifer Paterson, Miriam Bloch, George Csathy, David Allen, Patrizia Dell’Orto, Gitte Kjærsgaard, Yaron Y. Levy, Jan Trøst Jørgensen

Research output: Contribution to journalArticlepeer-review


The 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.

Original languageEnglish
Pages (from-to)1327-1335
Number of pages9
JournalHistology and Histopathology
Issue number12
Publication statusPublished - Dec 1 2016


  • Automation
  • Companion diagnostic
  • Gastric cancer
  • HER2

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Histology


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