Assessment of HER2 amplification status in breast cancer using a new automated HER2 IQFISH 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


In breast cancer the human epidermal growth factor receptor 2 (HER2) is an important target for a number of different HER2 inhibitors. Different slide-based assays are available for assessment of treatment eligibility, which include fluorescence in situ hybridization (FISH) or other in situ hybridization (ISH) methods for assessment of the HER2 gene status. 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. The assay uses a non-toxic buffer that significantly reduces the hybridization time, which results in a total turnaround time of 3½ to 4 h from deparaffinization to counting of the gene and centromere signals. The data reported in the current summary covers 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 a high precision that is at least comparable to the manual HER2 IQFISH pharmDx™ assay and the PathVysion® HER-2 DNA Probe Kit.

Original languageEnglish
Pages (from-to)735-742
Number of pages8
JournalPathology Research and Practice
Issue number8
Publication statusPublished - Aug 1 2016


  • Automation
  • Breast cancer
  • Companion diagnostic
  • HER2

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Cell Biology


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