PMID- 24372629 OWN - NLM STAT- MEDLINE DCOM- 20141121 LR - 20140826 IS - 1600-0463 (Electronic) IS - 0903-4641 (Linking) VI - 122 IP - 9 DP - 2014 Sep TI - Analysis of HER2 status in breast carcinoma by fully automated HER2 fluorescence in situ hybridization (FISH): comparison of two immunohistochemical tests and manual FISH. PG - 755-60 LID - 10.1111/apm.12215 [doi] AB - Easy and accurate HER2 testing is essential when considering the prognostic and predictive significance of HER2 in breast cancer. The use of a fully automated, quantitative FISH assay would be helpful to detect HER2 amplification in breast cancer tissue specimens with reduced inter-laboratory variability. We compared the concordance of HER2 status as assessed by an automated FISH staining system to manual FISH testing. Using 60 formalin-fixed paraffin-embedded breast carcinoma specimens, we assessed HER2 immunoexpression with two antibodies (DAKO HercepTest and CB11). In addition, HER2 status was evaluated with automated FISH using the Leica FISH System for BOND and a manual FISH using the Abbott PathVysion DNA Probe Kit. All but one specimen were successfully stained using both FISH methods. When the data were divided into two groups according to HER2/CEP17 ratio, positive and negative, the results from both the automated and manual FISH techniques were identical for all 59 evaluable specimens. The HER2 and CEP17 copy numbers and HER2/CEP17 ratio showed great agreement between both FISH methods. The automated FISH technique was interpretable with signal intensity similar to those of the manual FISH technique. In contrast with manual FISH, the automated FISH technique showed well-preserved architecture due to low membrane digestion. HER2 immunohistochemistry and FISH results showed substantial significant agreement (kappa = 1.0, p < 0.001). HER2 status can be reliably determined using a fully automated HER2 FISH system with high concordance to the well-established manual FISH method. Because of stable signal intensity and high staining quality, the automated FISH technique may be more appropriate than manual FISH for routine applications. CI - (c) 2013 APMIS. Published by John Wiley & Sons Ltd. FAU - Yoon, Nara AU - Yoon N AD - Department of Pathology, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea. FAU - Do, In-Gu AU - Do IG FAU - Cho, Eun Yoon AU - Cho EY LA - eng PT - Comparative Study PT - Journal Article DEP - 20131220 PL - Denmark TA - APMIS JT - APMIS : acta pathologica, microbiologica, et immunologica Scandinavica JID - 8803400 RN - 0 (Antibodies) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adult MH - Antibodies/immunology MH - *Automation, Laboratory MH - Breast Neoplasms/*diagnosis MH - Diagnostic Tests, Routine/methods MH - Female MH - Gene Amplification MH - Humans MH - Immunohistochemistry/methods MH - In Situ Hybridization, Fluorescence/*methods MH - Paraffin Embedding MH - Receptor, ErbB-2/*analysis/immunology/metabolism OTO - NOTNLM OT - Genes OT - automation OT - breast OT - carcinoma OT - ductal OT - erbB-2 OT - fluorescence OT - in situ hybridization EDAT- 2014/01/01 06:00 MHDA- 2014/12/15 06:00 CRDT- 2013/12/31 06:00 PHST- 2013/03/13 00:00 [received] PHST- 2013/10/21 00:00 [accepted] PHST- 2013/12/31 06:00 [entrez] PHST- 2014/01/01 06:00 [pubmed] PHST- 2014/12/15 06:00 [medline] AID - 10.1111/apm.12215 [doi] PST - ppublish SO - APMIS. 2014 Sep;122(9):755-60. doi: 10.1111/apm.12215. Epub 2013 Dec 20.