PMID- 25921313
OWN - NLM
STAT- MEDLINE
DCOM- 20160512
LR  - 20150708
IS  - 1532-8198 (Electronic)
IS  - 1092-9134 (Linking)
VI  - 19
IP  - 4
DP  - 2015 Aug
TI  - Gene protein detection platform--a comparison of a new human epidermal growth 
      factor receptor 2 assay with conventional immunohistochemistry and fluorescence 
      in situ hybridization platforms.
PG  - 203-10
LID - S1092-9134(15)00057-X [pii]
LID - 10.1016/j.anndiagpath.2015.04.002 [doi]
AB  - Human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) and 
      fluorescence in situ hybridization (FISH) are widely used semiquantitative assays 
      for selecting breast cancer patients for HER2 antibody therapy. However, both 
      techniques have been shown to have disadvantages. Our aim was to test a recent 
      automated technique of combined IHC and brightfield dual in situ 
      hybridization-gene protein detection platform (GPDP)-in breast cancer HER2 
      protein, gene, and chromosome 17 centromere status evaluations, comparing the 
      results in accordance to the American Society of Clinical Oncology/College of 
      American Pathologists recommendations for HER2 testing in breast cancer from both 
      2007 and 2013. The GPDP technique performance was evaluated on 52 consecutive 
      whole slide invasive breast cancer cases with HER2 IHC 2/3+ scoring results. 
      Applying in turns the American Society of Clinical Oncology/College of American 
      Pathologists recommendations for HER2 testing in breast cancer from 2007 and 2013 
      to both FISH and GPDP DISH assays, the HER2 gene amplification results showed 
      100% concordance among amplified/nonamplified cases, but there was a shift in 4 
      cases toward positive from equivocal results and toward equivocal from negative 
      results. This might be related to the emphasis on the average HER2 copy number in 
      the 2013 criteria. HER2 expression by IVD market IHC kit (Pathway(R)) has a strong 
      correlation with GPDP HER2 protein, including a full concordance for all cases 
      scored as 3+ and a reduction from 2+ to 1+ in 7 cases corresponding to 
      nonamplified cases. Gene protein detection platform HER2 protein "solo" could 
      have spared the need for 7 FISH studies. In addition, the platform offered 
      advantages on interpretation reassurance including selecting areas for counting 
      gene signals paralleled with protein IHC expression, on heterogeneity detection, 
      interpretation time, technical time, and tissue expense.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Stalhammar, Gustav
AU  - Stalhammar G
AD  - Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden; 
      St Erik Eye Hospital, Stockholm, Sweden. Electronic address: 
      gustav.stalhammar@ki.se.
FAU - Farrajota, Pedro
AU  - Farrajota P
AD  - Department of Clinical Pathology and Cytology, Karolinska University Hospital, 
      Stockholm, Sweden.
FAU - Olsson, Ann
AU  - Olsson A
AD  - Department of Clinical Pathology and Cytology, Karolinska University Hospital, 
      Stockholm, Sweden.
FAU - Silva, Cristina
AU  - Silva C
AD  - Oporto Hospital Center (CHP), Porto, Portugal.
FAU - Hartman, Johan
AU  - Hartman J
AD  - Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden; 
      Department of Clinical Pathology and Cytology, Karolinska University Hospital, 
      Stockholm, Sweden.
FAU - Elmberger, Goran
AU  - Elmberger G
AD  - Orebro University Hospital, Orebro, Sweden.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20150407
PL  - United States
TA  - Ann Diagn Pathol
JT  - Annals of diagnostic pathology
JID - 9800503
RN  - 0 (Biomarkers, Tumor)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Automation/methods
MH  - Biomarkers, Tumor/*analysis/biosynthesis/*genetics/metabolism
MH  - Breast Neoplasms/*chemistry/*genetics/metabolism/pathology
MH  - Chromosomes, Human, Pair 17
MH  - Female
MH  - Gene Amplification
MH  - Humans
MH  - Immunohistochemistry/*methods
MH  - In Situ Hybridization, Fluorescence/*methods
MH  - Receptor, ErbB-2/*analysis/biosynthesis/*genetics
OTO - NOTNLM
OT  - Breast
OT  - Dual ISH
OT  - GPDP
OT  - HER2
OT  - IHC
EDAT- 2015/04/30 06:00
MHDA- 2016/05/14 06:00
CRDT- 2015/04/30 06:00
PHST- 2015/02/07 00:00 [received]
PHST- 2015/03/31 00:00 [revised]
PHST- 2015/04/02 00:00 [accepted]
PHST- 2015/04/30 06:00 [entrez]
PHST- 2015/04/30 06:00 [pubmed]
PHST- 2016/05/14 06:00 [medline]
AID - S1092-9134(15)00057-X [pii]
AID - 10.1016/j.anndiagpath.2015.04.002 [doi]
PST - ppublish
SO  - Ann Diagn Pathol. 2015 Aug;19(4):203-10. doi: 10.1016/j.anndiagpath.2015.04.002. 
      Epub 2015 Apr 7.