PMID- 27461826
OWN - NLM
STAT- MEDLINE
DCOM- 20170323
LR  - 20191210
IS  - 1618-0631 (Electronic)
IS  - 0344-0338 (Linking)
VI  - 212
IP  - 8
DP  - 2016 Aug
TI  - Assessment of HER2 amplification status in breast cancer using a new automated 
      HER2 IQFISH pharmDx (Dako Omnis) assay.
PG  - 735-42
LID - S0344-0338(16)30156-X [pii]
LID - 10.1016/j.prp.2016.06.002 [doi]
AB  - 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 3(1/2) to 4h 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((R))HER-2 DNA Probe Kit.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier GmbH.. All rights reserved.
FAU - Viale, Giuseppe
AU  - Viale G
AD  - University of Milan, Istituto Europeo di Oncologia, Milan, Italy.
FAU - Paterson, Jennifer
AU  - Paterson J
AD  - UCL Advanced Diagnostics, London, UK.
FAU - Bloch, Miriam
AU  - Bloch M
AD  - Clarient Pathology Services, Aliso Viejo, CA, USA.
FAU - Csathy, George
AU  - Csathy G
AD  - Clarient Pathology Services, Aliso Viejo, CA, USA.
FAU - Allen, David
AU  - Allen D
AD  - UCL Advanced Diagnostics, London, UK.
FAU - Dell'Orto, Patrizia
AU  - Dell'Orto P
AD  - University of Milan, Istituto Europeo di Oncologia, Milan, Italy.
FAU - Kjaersgaard, Gitte
AU  - Kjaersgaard G
AD  - Dako, An Agilent Technologies Company, Glostrup, Denmark.
FAU - Levy, Yaron Y
AU  - Levy YY
AD  - Dako, An Agilent Technologies Company, Glostrup, Denmark.
FAU - Jorgensen, Jan Trost
AU  - Jorgensen JT
AD  - Dx-Rx Institute, Baunevaenget 76, DK-3480 Fredensborg, Denmark. Electronic 
      address: jan.trost@dx-rx.dk.
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20160608
PL  - Germany
TA  - Pathol Res Pract
JT  - Pathology, research and practice
JID - 7806109
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Breast Neoplasms/*diagnosis/*genetics/metabolism/pathology
MH  - Female
MH  - *Gene Amplification
MH  - Humans
MH  - In Situ Hybridization, Fluorescence/methods/*standards
MH  - Receptor, ErbB-2/*genetics/metabolism
MH  - Reproducibility of Results
OTO - NOTNLM
OT  - Automation
OT  - Breast cancer
OT  - Companion diagnostic
OT  - HER2
OT  - IQFISH
EDAT- 2016/07/28 06:00
MHDA- 2017/03/24 06:00
CRDT- 2016/07/28 06:00
PHST- 2016/01/13 00:00 [received]
PHST- 2016/05/09 00:00 [revised]
PHST- 2016/06/08 00:00 [accepted]
PHST- 2016/07/28 06:00 [entrez]
PHST- 2016/07/28 06:00 [pubmed]
PHST- 2017/03/24 06:00 [medline]
AID - S0344-0338(16)30156-X [pii]
AID - 10.1016/j.prp.2016.06.002 [doi]
PST - ppublish
SO  - Pathol Res Pract. 2016 Aug;212(8):735-42. doi: 10.1016/j.prp.2016.06.002. Epub 
      2016 Jun 8.