PMID- 23305906
OWN - NLM
STAT- MEDLINE
DCOM- 20130808
LR  - 20141120
IS  - 1943-7811 (Electronic)
IS  - 1525-1578 (Linking)
VI  - 15
IP  - 2
DP  - 2013 Mar
TI  - Automated quantitative RNA in situ hybridization for resolution of equivocal and 
      heterogeneous ERBB2 (HER2) status in invasive breast carcinoma.
PG  - 210-9
LID - S1525-1578(12)00315-7 [pii]
LID - 10.1016/j.jmoldx.2012.10.003 [doi]
AB  - Patient management based on HER2 status in breast carcinoma is an archetypical 
      example of personalized medicine but remains hampered by equivocal testing and 
      intratumoral heterogeneity. We developed a fully automated, quantitative, 
      bright-field in situ hybridization technique (RNAscope), applied it to quantify 
      single-cell HER2 mRNA levels in 132 invasive breast carcinomas, and compared the 
      results with those by real-time quantitative PCR (qPCR) and Food and Drug 
      Administration-approved methods, including fluorescence in situ hybridization 
      (FISH), IHC, chromogenic in situ hybridization, and dual in situ hybridization. 
      Both RNAscope and qPCR were 97.3% concordant with FISH in cases in which FISH 
      results were unequivocal. RNAscope was superior to qPCR in cases with 
      intratumoral heterogeneity or equivocal FISH results. This novel assay may enable 
      ultimate HER2 status resolution as a reflex test for current testing algorithms. 
      Quantitative in situ RNA measurement at the single-cell level may be broadly 
      applicable in companion diagnostic applications.
CI  - Copyright (c) 2013 American Society for Investigative Pathology and the Association 
      for Molecular Pathology. Published by Elsevier Inc. All rights reserved.
FAU - Wang, Zhen
AU  - Wang Z
AD  - Department of Molecular Pathology, Cleveland Clinic, Cleveland, Ohio 44195, USA.
FAU - Portier, Bryce P
AU  - Portier BP
FAU - Gruver, Aaron M
AU  - Gruver AM
FAU - Bui, Son
AU  - Bui S
FAU - Wang, Hongwei
AU  - Wang H
FAU - Su, Nan
AU  - Su N
FAU - Vo, Hong-Thuy
AU  - Vo HT
FAU - Ma, Xiao-Jun
AU  - Ma XJ
FAU - Luo, Yuling
AU  - Luo Y
FAU - Budd, G Thomas
AU  - Budd GT
FAU - Tubbs, Raymond R
AU  - Tubbs RR
LA  - eng
PT  - Journal Article
DEP - 20130108
PL  - United States
TA  - J Mol Diagn
JT  - The Journal of molecular diagnostics : JMD
JID - 100893612
RN  - 0 (RNA, Messenger)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Breast Neoplasms/diagnosis/*genetics/*pathology
MH  - Breast Neoplasms, Male/diagnosis/genetics/pathology
MH  - Carcinoma/diagnosis/*genetics/*pathology
MH  - Female
MH  - Humans
MH  - *In Situ Hybridization/methods
MH  - In Situ Hybridization, Fluorescence
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Grading
MH  - Neoplasm Invasiveness
MH  - Neoplasm Staging
MH  - *RNA, Messenger
MH  - Receptor, ErbB-2/*genetics
MH  - Sensitivity and Specificity
EDAT- 2013/01/12 06:00
MHDA- 2013/08/09 06:00
CRDT- 2013/01/12 06:00
PHST- 2012/06/04 00:00 [received]
PHST- 2012/10/04 00:00 [revised]
PHST- 2012/10/12 00:00 [accepted]
PHST- 2013/01/12 06:00 [entrez]
PHST- 2013/01/12 06:00 [pubmed]
PHST- 2013/08/09 06:00 [medline]
AID - S1525-1578(12)00315-7 [pii]
AID - 10.1016/j.jmoldx.2012.10.003 [doi]
PST - ppublish
SO  - J Mol Diagn. 2013 Mar;15(2):210-9. doi: 10.1016/j.jmoldx.2012.10.003. Epub 2013 
      Jan 8.