PMID- 19289584 OWN - NLM STAT- MEDLINE DCOM- 20090428 LR - 20151119 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 131 IP - 4 DP - 2009 Apr TI - Chromogenic in situ hybridization is a reliable method for detecting HER2 gene status in breast cancer: a multicenter study using conventional scoring criteria and the new ASCO/CAP recommendations. PG - 490-7 LID - 10.1309/AJCPI00TVGIGYXAA [doi] AB - Chromogenic in situ hybridization (CISH) has shown the potential to replace fluorescence in situ hybridization (FISH) to determine HER2 gene status. To validate the reliability of CISH, we used 226 consecutive breast carcinomas from 2 institutions and tested CISH and FISH on the same tumor set simultaneously at different test sites. Besides manufacturers' scoring criteria, the new American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines were used to interpret HER2 status. The concordance between CISH and FISH for positive and negative results was 98.5% at site A and 98.6% at site B using the manufacturers' criteria, and 99.0% at site A and 99.1% at site B using the ASCO/CAP criteria. Reproducibility of CISH results was more than 98.0% among 3 sites using the manufacturers' criteria and 100.0% between 2 sites using the ASCO/CAP criteria. Our results confirm that CISH is reliable for HER2 testing per ASCO/CAP guidelines. FAU - Gong, Yun AU - Gong Y AD - Department of Pathology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, USA. FAU - Sweet, William AU - Sweet W FAU - Duh, Yi-Jing AU - Duh YJ FAU - Greenfield, Larry AU - Greenfield L FAU - Fang, Yuan AU - Fang Y FAU - Zhao, Jianxin AU - Zhao J FAU - Tarco, Emily AU - Tarco E FAU - Symmans, W Fraser AU - Symmans WF FAU - Isola, Jorma AU - Isola J FAU - Sneige, Nour AU - Sneige N LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Chromogenic Compounds) SB - IM MH - Breast Neoplasms/*genetics MH - Chromogenic Compounds MH - Female MH - *Genes, erbB-2 MH - Guidelines as Topic MH - Humans MH - In Situ Hybridization/*methods MH - Reproducibility of Results MH - Retrospective Studies MH - Sensitivity and Specificity EDAT- 2009/03/18 09:00 MHDA- 2009/04/29 09:00 CRDT- 2009/03/18 09:00 PHST- 2009/03/18 09:00 [entrez] PHST- 2009/03/18 09:00 [pubmed] PHST- 2009/04/29 09:00 [medline] AID - 131/4/490 [pii] AID - 10.1309/AJCPI00TVGIGYXAA [doi] PST - ppublish SO - Am J Clin Pathol. 2009 Apr;131(4):490-7. doi: 10.1309/AJCPI00TVGIGYXAA.