PMID- 20584089 OWN - NLM STAT- MEDLINE DCOM- 20101105 LR - 20211020 IS - 1365-2559 (Electronic) IS - 0309-0167 (Print) IS - 0309-0167 (Linking) VI - 57 IP - 1 DP - 2010 Jul TI - Image analysis as an adjunct to manual HER-2 immunohistochemical review: a diagnostic tool to standardize interpretation. PG - 27-38 LID - 10.1111/j.1365-2559.2010.03577.x [doi] AB - AIMS: Accurate determination of HER-2 status is critical to identify patients for whom trastuzumab treatment will be of benefit. Although the recommended primary method of evaluation is immunohistochemistry, numerous reports of variability in interpretation have raised uncertainty about the reliability of results. Recent guidelines have suggested that image analysis could be an effective tool for achieving consistent interpretation, and this study aimed to assess whether this technology has potential as a diagnostic support tool. METHODS AND RESULTS: Across a cohort of 275 cases, image analysis could accurately classify HER-2 status, with 91% agreement between computer-aided classification and the pathology review. Assessment of the continuity of membranous immunoreactivity in addition to intensity of reactivity was critical to distinguish between negative and equivocal cases and enabled image analysis to report a lower referral rate of cases for confirmatory fluorescence in situ hybridization (FISH) testing. An excellent concordance rate of 95% was observed between FISH and the automated review across 136 informative cases. CONCLUSIONS: This study has validated that image analysis can robustly and accurately evaluate HER-2 status in immunohistochemically stained tissue. Based on these findings, image analysis has great potential as a diagnostic support tool for pathologists and biomedical scientists, and may significantly improve the standardization of HER-2 testing by providing a quantitative reference method for interpretation. FAU - Dobson, Lynne AU - Dobson L AD - SlidePath Ltd., Swift Square, Northwood Business Park, Santry, Dublin 9, Ireland. lynne.dobson@slidepath.com FAU - Conway, Catherine AU - Conway C FAU - Hanley, Alan AU - Hanley A FAU - Johnson, Alex AU - Johnson A FAU - Costello, Sean AU - Costello S FAU - O'Grady, Anthony AU - O'Grady A FAU - Connolly, Yvonne AU - Connolly Y FAU - Magee, Hilary AU - Magee H FAU - O'Shea, Daniel AU - O'Shea D FAU - Jeffers, Michael AU - Jeffers M FAU - Kay, Elaine AU - Kay E LA - eng PT - Comparative Study PT - Evaluation Study PT - Journal Article DEP - 20100624 PL - England TA - Histopathology JT - Histopathology JID - 7704136 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P188ANX8CK (Trastuzumab) SB - IM MH - Algorithms MH - Antibodies, Monoclonal/therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Agents/therapeutic use MH - Biomarkers, Tumor/analysis MH - Breast Neoplasms/*chemistry/*diagnosis/drug therapy/genetics MH - Cohort Studies MH - Diagnosis, Computer-Assisted MH - Female MH - Genes, erbB-2 MH - Humans MH - Image Processing, Computer-Assisted/*methods/standards MH - Immunohistochemistry/methods MH - In Situ Hybridization, Fluorescence MH - Receptor, ErbB-2/*analysis MH - Trastuzumab PMC - PMC2916223 EDAT- 2010/06/30 06:00 MHDA- 2010/11/06 06:00 CRDT- 2010/06/30 06:00 PHST- 2010/06/30 06:00 [entrez] PHST- 2010/06/30 06:00 [pubmed] PHST- 2010/11/06 06:00 [medline] AID - HIS3577 [pii] AID - 10.1111/j.1365-2559.2010.03577.x [doi] PST - ppublish SO - Histopathology. 2010 Jul;57(1):27-38. doi: 10.1111/j.1365-2559.2010.03577.x. Epub 2010 Jun 24.