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

• Giuseppe Viale ^[1] ; Jennifer Paterson ^[2] ; Miriam Bloch ^[3] ; George Csathy ^[3] ; David Allen ^[2] ; Patrizia Dell'Orto ^[1] ; Gitte Kjærsgaard ^[4] ; Yaron Y. Levy ^[4] ; Jan Trøst Jørgensen ^[5]
  1. [1] University of Milan

     University of Milan

     Milán, Italia

     
  2. [2] UCL Advanced Diagnostics
  3. [3] Clarient Pathology Services
  4. [4] Dako, An Agilent Technologies Company
  5. [5] Dx-Rx Institute, Fredensborg

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• Localización: Histology and histopathology: cellular and molecular biology, ISSN-e 1699-5848, ISSN 0213-3911, Vol. 31, Nº. 12, 2016, págs. 1327-1335
• Idioma: inglés
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  • 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 immunohisto-chemistry (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