Publication: Analysis of HER2 status in gastroesophageal tumor specimens using a new automated HER2 IQFISH pharmDx™ (Dako Omnis) assay
Authors
Viale, Giuseppe ; Paterson, Jennifer ; Bloch, Miriam ; Csathy, George ; Allen, David ; Dell’Orto, Patrizia ; Kjærsgaard, Gitte ; Levy, Yaron Y. ; Trøst Jørgensen, Jan
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Publisher
Universidad de Murcia. Departamento de Biología Celular e Histología
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DOI
DOI: 10.14670/HH-11-759
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info:eu-repo/semantics/article
Description
Abstract
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.
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Citation
Histology and Histopathology, Vol.31, nº12, (2016)
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