PMID- 32154039
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220729
IS  - 2229-5089 (Print)
IS  - 2153-3539 (Electronic)
VI  - 11
DP  - 2020
TI  - A Validation Study of Human Epidermal Growth Factor Receptor 2 
      Immunohistochemistry Digital Imaging Analysis and its Correlation with Human 
      Epidermal Growth Factor Receptor 2 Fluorescence In situ Hybridization Results in 
      Breast Carcinoma.
PG  - 2
LID - 10.4103/jpi.jpi_52_19 [doi]
LID - 2
AB  - BACKGROUND: The Visiopharm human epidermal growth factor receptor 2 (HER2) 
      digital imaging analysis (DIA) algorithm assesses digitized HER2 
      immunohistochemistry (IHC) by measuring cell membrane connectivity. We aimed to 
      validate this algorithm for clinical use by comparing with pathologists' scoring 
      and correlating with HER2 fluorescence in situ hybridization (FISH) results. 
      MATERIALS AND METHODS: The study cohort consisted of 612 consecutive invasive 
      breast carcinoma specimens including 395 biopsies and 217 resections. HER2 IHC 
      slides were scanned using Philips IntelliSite Scanners, and the digital images 
      were analyzed using Visiopharm HER2-CONNECT App to obtain the connectivity values 
      (0-1) and scores (0, 1+, 2+, and 3+). HER2 DIA scores were compared with 
      Pathologists' manual scores, and HER2 connectivity values were correlated with 
      HER2 FISH results. RESULTS: The concordance between HER2 DIA scores and 
      pathologists' scores was 87.3% (534/612). All discordant cases (n = 78) were only 
      one-step discordant (negative to equivocal, equivocal to positive, or vice 
      versa). Five cases (0.8%) showed discordant HER2 IHC DIA and HER2 FISH results, 
      but all these cases had relatively low HER2 copy numbers (between 4 and 6). HER2 
      IHC connectivity showed significantly better correlation with HER2 copy number 
      than HER2/CEP17 ratio. CONCLUSIONS: HER2 IHC DIA demonstrates excellent 
      concordance with pathologists' scores and accurately discriminates between HER2 
      FISH positive and negative cases. HER2 IHC connectivity has better correlation 
      with HER2 copy number than HER2/CEP17 ratio, suggesting HER2 copy number may be 
      more important in predicting HER2 protein expression, and response to 
      anti-HER2-targeted therapy.
CI  - Copyright: (c) 2020 Journal of Pathology Informatics.
FAU - Hartage, Ramon
AU  - Hartage R
AD  - Department of Pathology, The Ohio State University Wexner Medical Center, 
      Columbus, OH 43210, USA.
FAU - Li, Aidan C
AU  - Li AC
AD  - Department of NA, Jerome High School, Dublin, OH 43017, USA.
FAU - Hammond, Scott
AU  - Hammond S
AD  - Department of Pathology, The Ohio State University Wexner Medical Center, 
      Columbus, OH 43210, USA.
FAU - Parwani, Anil V
AU  - Parwani AV
AD  - Department of Pathology, The Ohio State University Wexner Medical Center, 
      Columbus, OH 43210, USA.
LA  - eng
PT  - Journal Article
DEP - 20200204
PL  - United States
TA  - J Pathol Inform
JT  - Journal of pathology informatics
JID - 101528849
PMC - PMC7032021
OTO - NOTNLM
OT  - Breast carcinoma
OT  - Visiopharm
OT  - digital imaging analysis
OT  - fluorescence in situ hybridization
OT  - human epidermal growth factor receptor 2
OT  - immunohistochemistry
COIS- There are no conflicts of interest.
EDAT- 2020/03/11 06:00
MHDA- 2020/03/11 06:01
PMCR- 2020/02/04
CRDT- 2020/03/11 06:00
PHST- 2019/09/09 00:00 [received]
PHST- 2019/10/16 00:00 [accepted]
PHST- 2020/03/11 06:00 [entrez]
PHST- 2020/03/11 06:00 [pubmed]
PHST- 2020/03/11 06:01 [medline]
PHST- 2020/02/04 00:00 [pmc-release]
AID - S2153-3539(22)00231-0 [pii]
AID - JPI-11-2 [pii]
AID - 10.4103/jpi.jpi_52_19 [doi]
PST - epublish
SO  - J Pathol Inform. 2020 Feb 4;11:2. doi: 10.4103/jpi.jpi_52_19. eCollection 2020.