PMID- 37490416
OWN - NLM
STAT- MEDLINE
DCOM- 20240326
LR  - 20240326
IS  - 1543-2165 (Electronic)
IS  - 0003-9985 (Linking)
VI  - 148
IP  - 4
DP  - 2024 Apr 1
TI  - Validation of Dual-Color Dual In Situ Hybridization for HER2/neu Gene in Breast 
      Cancer.
PG  - 453-460
LID - 10.5858/arpa.2022-0543-OA [doi]
AB  - CONTEXT.-: Human epidermal growth factor (HER2/neu) gene amplification, a poor 
      prognostic factor in invasive breast cancer, has shown substantial utility as a 
      predictive marker, with significantly improved survival following anti-HER2 
      therapies like trastuzumab. Dual-color dual in situ hybridization (D-DISH), a 
      recently introduced fully automated assay for HER2/neu evaluation on light 
      microscopy, has several advantages over fluorescence in situ hybridization 
      (FISH). OBJECTIVE.-: To standardize and validate the D-DISH assay using FISH as 
      the gold standard and assess interobserver reproducibility in interpreting the 
      D-DISH assay. DESIGN.-: D-DISH was performed using the latest HER2 Dual ISH DNA 
      Probe Cocktail assay (Ventana Medical Systems Inc, Tucson, Arizona) in 148 cases 
      of invasive breast cancer. The same block was used for performing 
      immunohistochemistry by Ventana PATHWAY anti-HER2/neu (4B5) antibody and FISH 
      assay by ZytoLight SPEC ERBB2/CEN17 Dual Color Probe. D-DISH was separately 
      interpreted by 4 pathologists blinded to FISH results. RESULTS.-: Concordance of 
      98.65% and a Cohen kappa value of 0.97 were observed between FISH and D-DISH. 
      Intraclass correlation coefficient (0.93-0.97) and kappa values (0.98-1.0) for 
      interobserver reproducibility showed almost perfect agreement by D-DISH. 
      Interobserver reproducibility was also evaluated for genomic heterogeneity, HER2 
      group categorization, and polysomy (kappa values 0.42-0.74, 0.89-0.93, and 0.98-1.0, 
      respectively). CONCLUSIONS.-: We successfully validated the latest version of 
      D-DISH assay as a substitute for FISH in predicting HER2 gene status with 
      significant interobserver reproducibility, concluding that this D-DISH assay may 
      be introduced in routine diagnostic services as a reflex test to ascertain HER2 
      gene status.
CI  - (c) 2024 College of American Pathologists.
FAU - Rathi, Aditi
AU  - Rathi A
AD  - From the Department of Pathology, Tata Memorial Centre, Homi Bhabha National 
      Institute, Mumbai, India.
FAU - Sahay, Ayushi
AU  - Sahay A
AD  - From the Department of Pathology, Tata Memorial Centre, Homi Bhabha National 
      Institute, Mumbai, India.
FAU - Shet, Tanuja M
AU  - Shet TM
AD  - From the Department of Pathology, Tata Memorial Centre, Homi Bhabha National 
      Institute, Mumbai, India.
FAU - Patil, Asawari
AU  - Patil A
AD  - From the Department of Pathology, Tata Memorial Centre, Homi Bhabha National 
      Institute, Mumbai, India.
FAU - Desai, Sangeeta B
AU  - Desai SB
AD  - From the Department of Pathology, Tata Memorial Centre, Homi Bhabha National 
      Institute, Mumbai, India.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Arch Pathol Lab Med
JT  - Archives of pathology & laboratory medicine
JID - 7607091
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Genes, erbB-2
MH  - *Breast Neoplasms/diagnosis
MH  - In Situ Hybridization, Fluorescence/methods
MH  - Reproducibility of Results
MH  - Receptor, ErbB-2/genetics/metabolism
MH  - Immunohistochemistry
COIS- The authors have no relevant financial interest in the products or companies 
      described in this article.
EDAT- 2023/07/25 19:15
MHDA- 2024/03/26 06:44
CRDT- 2023/07/25 13:13
PHST- 2023/04/07 00:00 [accepted]
PHST- 2024/03/26 06:44 [medline]
PHST- 2023/07/25 19:15 [pubmed]
PHST- 2023/07/25 13:13 [entrez]
AID - 494584 [pii]
AID - 10.5858/arpa.2022-0543-OA [doi]
PST - ppublish
SO  - Arch Pathol Lab Med. 2024 Apr 1;148(4):453-460. doi: 10.5858/arpa.2022-0543-OA.