PMID- 25602790
OWN - NLM
STAT- MEDLINE
DCOM- 20150615
LR  - 20151119
IS  - 1532-0979 (Electronic)
IS  - 0147-5185 (Linking)
VI  - 39
IP  - 5
DP  - 2015 May
TI  - Quantification of human epidermal growth factor receptor 2 immunohistochemistry 
      using the Ventana Image Analysis System: correlation with gene amplification by 
      fluorescence in situ hybridization: the importance of instrument validation for 
      achieving high (>95%) concordance rate.
PG  - 624-31
LID - 10.1097/PAS.0000000000000375 [doi]
AB  - The use of computer-based image analysis for scoring human epidermal growth 
      factor receptor 2 (HER2) immunohistochemistry (IHC) has gained a lot of interest 
      recently. We investigated the performance of the Ventana Image Analysis System 
      (VIAS) in HER2 quantification by IHC and its correlation with fluorescence in 
      situ hybridization (FISH). We specifically compared the 3+ IHC results using the 
      manufacturer's machine score cutoffs versus laboratory-defined cutoffs with the 
      FISH assay. Using the manufacturer's 3+ cutoff (VIAS score; 2.51 to 3.5), 181/536 
      (33.7%) were scored 3+, and FISH was positive in 147/181 (81.2%), 2 (1.1%) were 
      equivocal, and 32 (17.6%) were FISH (-). Using the laboratory-defined 3+ cutoff 
      (VIAS score 3.5), 52 (28.7%) cases were downgraded to 2+, of which 29 (55.7%) 
      were FISH (-), and 23 (44.2%) were FISH (+). With the revised cutoff, there were 
      improvements in the concordance rate from 89.1% to 97.0% and in the positive 
      predictive value from 82.1% to 97.6%. The false-positive rate for 3+ decreased 
      from 9.0% to 0.8%. Six of 175 (3.4%) IHC (-) cases were FISH (+). Three cases 
      with a VIAS score 3.5 showed polysomy of chromosome 17. In conclusion, the VIAS 
      may be a valuable tool for assisting pathologists in HER2 scoring; however, the 
      positive cutoff defined by the manufacturer is associated with a high 
      false-positive rate. This study highlights the importance of instrument 
      validation/calibration to reduce false-positive results.
FAU - Dennis, Jake
AU  - Dennis J
AD  - Department of Pathology, UT Southwestern Medical Center, Dallas, TX.
FAU - Parsa, Rezvaneh
AU  - Parsa R
FAU - Chau, Donnie
AU  - Chau D
FAU - Koduru, Prasad
AU  - Koduru P
FAU - Peng, Yan
AU  - Peng Y
FAU - Fang, Yisheng
AU  - Fang Y
FAU - Sarode, Venetia Rumnong
AU  - Sarode VR
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Am J Surg Pathol
JT  - The American journal of surgical pathology
JID - 7707904
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/*analysis
MH  - Breast Neoplasms/*genetics
MH  - Calibration
MH  - Female
MH  - Gene Amplification
MH  - Humans
MH  - Image Processing, Computer-Assisted/*instrumentation
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - Receptor, ErbB-2/*analysis/biosynthesis/genetics
MH  - Reproducibility of Results
EDAT- 2015/01/21 06:00
MHDA- 2015/06/16 06:00
CRDT- 2015/01/21 06:00
PHST- 2015/01/21 06:00 [entrez]
PHST- 2015/01/21 06:00 [pubmed]
PHST- 2015/06/16 06:00 [medline]
AID - 10.1097/PAS.0000000000000375 [doi]
PST - ppublish
SO  - Am J Surg Pathol. 2015 May;39(5):624-31. doi: 10.1097/PAS.0000000000000375.