PMID- 19864244 OWN - NLM STAT- MEDLINE DCOM- 20091112 LR - 20151119 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 132 IP - 1 DP - 2009 Jul TI - Automated cellular imaging system III for assessing HER2 status in breast cancer specimens: development of a standardized scoring method that correlates with FISH. PG - 133-8 LID - 10.1309/AJCPJV0SKAF2PCMY [doi] AB - The goal of this study was to assess the performance characteristics of the Automated Cellular Imaging System (ACIS III) for HER2 immunohistochemical analysis. The study was performed on 187 biopsy slides from patients who underwent HER2 testing between January and February 2008. Three scoring methods by the ACIS III were compared with the manual score and fluorescence in situ hybridization (FISH) results for HER2 amplification. The equal distribution score (EQD) method, in which 2 areas each of high-, moderate-, and low-intensity staining were measured, most closely matched the FISH HER2 amplification result. The numbers of immunohistochemically negative (0 or 1+)/FISH+ cases were equivalent for all methods. The EQD method had significantly fewer 2+ cases (n = 16) (P < .001) vs the manual method (n = 35) and yielded a higher positive predictive value (38%) for HER2 amplification compared with the manual method (20%). The EQD method may more accurately identify FISH-amplified HER2 cases with fewer 2+ cases that would be "reflexed" to FISH compared with the manual method. FAU - Minot, Douglas M AU - Minot DM AD - Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USA. FAU - Kipp, Benjamin R AU - Kipp BR FAU - Root, Renee M AU - Root RM FAU - Meyer, Reid G AU - Meyer RG FAU - Reynolds, Carol A AU - Reynolds CA FAU - Nassar, Aziza AU - Nassar A FAU - Henry, Michael R AU - Henry MR FAU - Clayton, Amy C AU - Clayton AC LA - eng PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Biomarkers, Tumor) RN - 0 (DNA, Neoplasm) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Biomarkers, Tumor/metabolism MH - Breast Neoplasms/genetics/*metabolism/*pathology MH - DNA, Neoplasm/analysis MH - Female MH - Gene Amplification MH - Gene Expression Regulation, Neoplastic MH - Humans MH - Image Processing, Computer-Assisted/*methods MH - Immunohistochemistry MH - In Situ Hybridization, Fluorescence MH - Middle Aged MH - Receptor, ErbB-2/*metabolism MH - Reproducibility of Results MH - Retrospective Studies MH - Young Adult EDAT- 2009/10/30 06:00 MHDA- 2009/11/13 06:00 CRDT- 2009/10/30 06:00 PHST- 2009/10/30 06:00 [entrez] PHST- 2009/10/30 06:00 [pubmed] PHST- 2009/11/13 06:00 [medline] AID - 132/1/133 [pii] AID - 10.1309/AJCPJV0SKAF2PCMY [doi] PST - ppublish SO - Am J Clin Pathol. 2009 Jul;132(1):133-8. doi: 10.1309/AJCPJV0SKAF2PCMY.