PMID- 36920020
OWN - NLM
STAT- MEDLINE
DCOM- 20231128
LR  - 20231129
IS  - 1543-2165 (Electronic)
IS  - 0003-9985 (Linking)
VI  - 147
IP  - 12
DP  - 2023 Dec 1
TI  - Quantitative Imaging Analysis Fluorescence In Situ Hybridization Validation for 
      Clinical HER2 Testing in Breast Cancer.
PG  - 1402-1412
LID - 10.5858/arpa.2022-0372-OA [doi]
AB  - CONTEXT.-: Quantitative imaging is a promising tool that is gaining wide use 
      across several areas of pathology. Although there has been increasing adoption of 
      morphologic and immunohistochemical analysis, the adoption of evaluation of 
      fluorescence in situ hybridization (FISH) on formalin-fixed, paraffin-embedded 
      tissue has been limited because of complexity and lack of practice guidelines. 
      OBJECTIVE.-: To perform human epidermal growth factor receptor 2 (HER2) FISH 
      validation in breast carcinoma in accordance with the American Society of 
      Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 guideline. 
      DESIGN.-: Clinical validation of HER2 FISH was performed using the US Food and 
      Drug Administration-approved dual-probe HER2 IQFISH (Dako, Carpinteria, 
      California) with digital scanning performed on a PathFusion (Applied Spectral 
      Imaging, Carlsbad, California) system. Validation parameters evaluated included 
      z-stacking, classifier, accuracy, precision, software, and hardware settings. 
      Finally, we evaluated the performance of digital enumeration on clinical samples 
      in a real-world setting. RESULTS.-: The accuracy samples showed a final 
      concordance of 95.3% to 100% across HER2 groups 1 to 5. During clinical 
      implementation for HER2 groups 2, 3, and 4, we achieved a final concordance of 
      76% (95 of 125). Of these cases, only 8% (10 of 125) had discordances with 
      clinical impact that could be identified algorithmically and triaged for manual 
      review. CONCLUSIONS.-: Digital FISH enumeration is a useful tool to improve the 
      efficacy of HER2 FISH enumeration and capture genetic heterogeneity across HER2 
      signals. Excluding cases with high background or poor image quality and manual 
      review of cases with ASCO/CAP group discordances can further improve the 
      efficiency of digital HER2 FISH enumeration.
CI  - (c) 2023 College of American Pathologists.
FAU - Wilcock, Diane M
AU  - Wilcock DM
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Moore, Kristina H
AU  - Moore KH
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Rowe, Leslie
AU  - Rowe L
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Mahlow, Jonathan
AU  - Mahlow J
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Jedrzkiewicz, Jolanta
AU  - Jedrzkiewicz J
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Cleary, Allison S
AU  - Cleary AS
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Lomo, Lesley
AU  - Lomo L
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Ruano, Ana L
AU  - Ruano AL
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Gering, Maarika
AU  - Gering M
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Bradshaw, Derek
AU  - Bradshaw D
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Maughan, Meghan
AU  - Maughan M
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Tran, Phuong
AU  - Tran P
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Burlingame, Jesse
AU  - Burlingame J
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Davis, Richard
AU  - Davis R
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Affolter, Kajsa
AU  - Affolter K
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Albertson, Daniel J
AU  - Albertson DJ
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Adelhardt, Parisa
AU  - Adelhardt P
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Kim, Jong Take
AU  - Kim JT
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Coleman, Joshua F
AU  - Coleman JF
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Deftereos, Georgios
AU  - Deftereos G
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Gulbahce, Evin H
AU  - Gulbahce EH
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
FAU - Sirohi, Deepika
AU  - Sirohi D
AD  - From the Institute for Experimental Pathology, ARUP Laboratories, Salt Lake City, 
      Utah (Wilcock, Moore, Rowe, Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Gering, 
      Bradshaw, Maughan, Tran, Burlingame, Davis, Affolter, Albertson, Adelhardt, Kim, 
      Coleman, Deftereos, Gulbahce, Sirohi).
AD  - The Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake 
      City (Mahlow, Jedrzkiewicz, Cleary, Lomo, Ruano, Affolter, Albertson, Adelhardt, 
      Kim, Coleman, Deftereos, Gulbahce, Sirohi).
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)
RN  - 0 (Biomarkers, Tumor)
SB  - IM
MH  - Humans
MH  - Female
MH  - *Breast Neoplasms/diagnostic imaging/genetics
MH  - In Situ Hybridization, Fluorescence/methods
MH  - Receptor, ErbB-2/analysis
MH  - Biomarkers, Tumor/analysis
EDAT- 2023/03/16 06:00
MHDA- 2023/11/28 06:42
CRDT- 2023/03/15 08:43
PHST- 2022/12/05 00:00 [accepted]
PHST- 2023/11/28 06:42 [medline]
PHST- 2023/03/16 06:00 [pubmed]
PHST- 2023/03/15 08:43 [entrez]
AID - 490201 [pii]
AID - 10.5858/arpa.2022-0372-OA [doi]
PST - ppublish
SO  - Arch Pathol Lab Med. 2023 Dec 1;147(12):1402-1412. doi: 
      10.5858/arpa.2022-0372-OA.