PMID- 21386703 OWN - NLM STAT- MEDLINE DCOM- 20120124 LR - 20161020 IS - 1533-4058 (Electronic) IS - 1533-4058 (Linking) VI - 19 IP - 5 DP - 2011 Oct TI - HER2 testing: how to reach a high concordance rate between immunohistochemistry and fluorescence in situ hybridization. PG - 424-30 LID - 10.1097/PAI.0b013e31820b62be [doi] AB - BACKGROUND: The concordance rate between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for human epidermal growth factor receptor-2 (HER2) is still a major clinical concern. We describe a new criteria evaluating HER2 IHC. MATERIALS AND METHODS: We expanded the equivocal category to include the American Society of Clinical Oncology and College of American Pathologists equivocal category and cases with 3+ between 30% to 90% of tumor cells and 2+ in >/=1% of tumor cells. Then, we prospectively evaluated 106 cases with FISH. RESULTS: There were 2 categories that were not required to be tested by FISH based on American Society of Clinical Oncology and College of American Pathologists criteria. The first category, cases with 2+staining between >/=1% and <10%. In this category, there were 15 cases, 2 (13.3%) had HER2 amplification by FISH. The second category, cases with 3+ staining between 30% and 90%. In this category, there were 16 cases, 5 (31.3%) were not amplified and 1 (6.3%) was borderline. CONCLUSIONS: Expanding the equivocal category could increase the concordance rate between IHC and FISH with minimal additional cost. FAU - Khoury, Thaer AU - Khoury T AD - Department of Pathology, Roswell Park Cancer Institute, Buffalo, NY 14263, USA. thaer.khoury@roswellpark.org FAU - Kulkarni, Swati AU - Kulkarni S FAU - Morrison, Carl AU - Morrison C FAU - Bshara, Wiam AU - Bshara W FAU - Zakharia, Yousef AU - Zakharia Y FAU - Edge, Stephen AU - Edge S LA - eng PT - Journal Article PL - United States TA - Appl Immunohistochem Mol Morphol JT - Applied immunohistochemistry & molecular morphology : AIMM JID - 100888796 RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Diagnostic Techniques and Procedures/standards MH - False Negative Reactions MH - False Positive Reactions MH - Female MH - Humans MH - *Immunohistochemistry MH - *In Situ Hybridization, Fluorescence MH - Middle Aged MH - *Receptor, ErbB-2/analysis MH - Research Design MH - United States MH - United States Food and Drug Administration EDAT- 2011/03/10 06:00 MHDA- 2012/01/25 06:00 CRDT- 2011/03/10 06:00 PHST- 2011/03/10 06:00 [entrez] PHST- 2011/03/10 06:00 [pubmed] PHST- 2012/01/25 06:00 [medline] AID - 10.1097/PAI.0b013e31820b62be [doi] PST - ppublish SO - Appl Immunohistochem Mol Morphol. 2011 Oct;19(5):424-30. doi: 10.1097/PAI.0b013e31820b62be.