PMID- 24075600
OWN - NLM
STAT- MEDLINE
DCOM- 20140108
LR  - 20191210
IS  - 1532-8392 (Electronic)
IS  - 0046-8177 (Linking)
VI  - 44
IP  - 11
DP  - 2013 Nov
TI  - Validation and workflow optimization of human epidermal growth factor receptor 2 
      testing using INFORM HER2 dual-color in situ hybridization.
PG  - 2590-6
LID - S0046-8177(13)00292-X [pii]
LID - 10.1016/j.humpath.2013.07.005 [doi]
AB  - Human epidermal growth factor receptor 2 (HER2) status is useful for predicting 
      response to trastuzumab. Fluorescence in situ hybridization (FISH) for HER2 gene 
      amplification is accurate but limited because of cost, the need for fluorescence 
      microscopy, the limited assessment of histology, and the fading of its signal 
      over time. Dual-color in situ hybridization (Dual ISH) is fully automated, is 
      viewable by bright-field microscopy, has a stable signal, and has separate colors 
      for HER2 and chromosome 17 signals. HER2 immunohistochemistry (IHC), FISH, and 
      Dual ISH were performed on 101 breast cancer cases. Sixteen of 17 cases with 3+ 
      HER2 by IHC showed gene amplification by FISH, and 15 showed amplification by 
      Dual ISH. Three of the 2+ IHC cases were either amplified or equivocal by Dual 
      ISH. None of the IHC-negative cases were amplified by either FISH or Dual ISH. 
      Dual ISH agreed with FISH in 93% of cases. Among the 6 discrepancies, 4 were for 
      an equivocal result for 1 test compared with either a positive or a negative 
      result for the other test. The average differences in readings between Dual ISH 
      and FISH in the discrepant cases were only 0.02, with a range of -1.37 to 1.85. 
      Turnaround time for FISH as a send-out test from test ordering to reporting 
      averaged 8.27 workdays, whereas the turnaround time for Dual ISH performed 
      in-house averaged 4.94 workdays (P < .0000001). Our results indicated that 
      automated Dual ISH is a useful method for evaluating HER2 status in a clinical 
      setting.
CI  - (c) 2013.
FAU - Lim, Sung-Jig
AU  - Lim SJ
AD  - Department of Pathology, Kyung Hee University Hospital at Gangdong, Kyung Hee 
      University School of Medicine, Seoul 134-727, South Korea.
FAU - Cantillep, Alegria
AU  - Cantillep A
FAU - Carpenter, Philip M
AU  - Carpenter PM
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Validation Study
DEP - 20130925
PL  - United States
TA  - Hum Pathol
JT  - Human pathology
JID - 9421547
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  - Biomarkers, Tumor/*metabolism
MH  - Biopsy
MH  - Breast Neoplasms/*metabolism/pathology/surgery
MH  - Carcinoma/*metabolism/pathology/surgery
MH  - Female
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization/*methods
MH  - In Situ Hybridization, Fluorescence/methods
MH  - Prospective Studies
MH  - Receptor, ErbB-2/*metabolism
MH  - Retrospective Studies
MH  - Time Factors
OTO - NOTNLM
OT  - Breast carcinoma
OT  - CISH
OT  - Chr17
OT  - DNP
OT  - Dual ISH
OT  - Dual-color in situ hybridization
OT  - ER
OT  - FDA
OT  - FFPE
OT  - FISH
OT  - Fluorescence in situ hybridization
OT  - GOLDFISH
OT  - HER2
OT  - IHC
OT  - INFORM HER2 Dual-color in situ hybridization
OT  - ISH
OT  - PR
OT  - SISH
OT  - TAT
OT  - Turnaround time
OT  - United States Food and Drug Administration
OT  - chromogenic in situ hybridization
OT  - chromosome 17 centromere
OT  - dinitrophenyl
OT  - estrogen receptor
OT  - fluorescence in situ hybridization
OT  - formalin-fixed, paraffin-embedded
OT  - human epidermal growth factor receptor 2
OT  - immunohistochemistry
OT  - in situ hybridization
OT  - nanogold with enhancement in situ hybridization
OT  - progesterone receptor
OT  - silver-enhanced in situ hybridization
OT  - turnaround time
EDAT- 2013/10/01 06:00
MHDA- 2014/01/09 06:00
CRDT- 2013/10/01 06:00
PHST- 2013/04/04 00:00 [received]
PHST- 2013/06/29 00:00 [revised]
PHST- 2013/07/03 00:00 [accepted]
PHST- 2013/10/01 06:00 [entrez]
PHST- 2013/10/01 06:00 [pubmed]
PHST- 2014/01/09 06:00 [medline]
AID - S0046-8177(13)00292-X [pii]
AID - 10.1016/j.humpath.2013.07.005 [doi]
PST - ppublish
SO  - Hum Pathol. 2013 Nov;44(11):2590-6. doi: 10.1016/j.humpath.2013.07.005. Epub 2013 
      Sep 25.