PMID- 25696805 OWN - NLM STAT- MEDLINE DCOM- 20150427 LR - 20151119 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 143 IP - 3 DP - 2015 Mar TI - Dual HER2 gene protein assay: focused study of breast cancers with 2+ immunohistochemical expression. PG - 451-8 LID - 10.1309/AJCPKIVVW4OBPX6I [doi] AB - OBJECTIVES: The combined gene protein assay (GPA) can simultaneously assess HER2 gene copy number and protein on a single slide using bright-field microscopy. METHODS: GPA was compared with a fluorescence in situ hybridization (FISH) assay on 50 invasive breast carcinomas with a 2+ score on immunohistochemistry (IHC). RESULTS: The cases were categorized into positive, equivocal, or negative for HER2 gene amplification using the 2013 American Society of Clinical Oncology/College of American Pathologists criteria. This resulted in 82% agreement (41 of 50) between FISH and GPA. In addition, 25 known IHC 3+ breast carcinomas analyzed by GPA showed protein overexpression and clusters of HER2 gene consistent with unequivocal amplification, and 22 known IHC-negative cases were negative for HER2 gene amplification by GPA. CONCLUSIONS: Although GPA is an alternative to both IHC and FISH, it may be an unnecessary test for IHC 0/1+/3+ cases. The clinical utility of GPA appears to be similar to other in situ hybridization assays (ie, adjudicator of HER2 status for IHC 2+ cases). CI - Copyright(c) by the American Society for Clinical Pathology. FAU - Li, Zaibo AU - Li Z AD - From the Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, and. FAU - Dabbs, David J AU - Dabbs DJ AD - From the Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, and. FAU - Cooper, Kristine L AU - Cooper KL AD - University of Pittsburgh Cancer Institute Biostatistics Facility, Pittsburgh, PA. FAU - Bhargava, Rohit AU - Bhargava R AD - From the Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, and rbhargava@mail.magee.edu. LA - eng GR - P30CA047904/CA/NCI NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Research Support, N.I.H., Extramural PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - *Biomarkers, Tumor/genetics/metabolism MH - Breast Neoplasms/genetics/metabolism/*pathology MH - Carcinoma, Ductal, Breast/metabolism/*pathology MH - Female MH - Gene Amplification MH - Gene Dosage MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Protein Array Analysis MH - *Receptor, ErbB-2/genetics/metabolism OTO - NOTNLM OT - FISH OT - GPA OT - HER2 gene OT - HER2 immunohistochemistry OT - IHC score 2+ EDAT- 2015/02/20 06:00 MHDA- 2015/04/29 06:00 CRDT- 2015/02/20 06:00 PHST- 2015/02/20 06:00 [entrez] PHST- 2015/02/20 06:00 [pubmed] PHST- 2015/04/29 06:00 [medline] AID - 143/3/451 [pii] AID - 10.1309/AJCPKIVVW4OBPX6I [doi] PST - ppublish SO - Am J Clin Pathol. 2015 Mar;143(3):451-8. doi: 10.1309/AJCPKIVVW4OBPX6I.