PMID- 12591971 OWN - NLM STAT- MEDLINE DCOM- 20030805 LR - 20141120 IS - 0893-3952 (Print) IS - 0893-3952 (Linking) VI - 16 IP - 2 DP - 2003 Feb TI - Current perspectives on HER2 testing: a review of national testing guidelines. PG - 173-82 AB - Knowledge of HER2 status is a prerequisite when considering a patient's eligibility for Herceptin (trastuzumab) therapy. Accurate assessment of HER2 status is essential to ensure that all patients who may benefit from Herceptin are correctly identified. There are several assays available to determine HER2 status: the most common in routine clinical practice are immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Various factors can affect the results achieved with these assays, including the assay antibody/probe, the methodology and the experience of personnel. Many countries have implemented national testing guidelines in an attempt to standardize testing procedures and make results more accurate. These guidelines vary in the level of detail and the number of recommendations. This review looks at areas of consensus between the different national testing guidelines and highlights where errors may arise during the testing procedure. The key point underlined by this review is that whatever method is used to test for HER2 status, the technology must be validated first, and there must be regular internal and external quality control and quality assurance procedures. FAU - Bilous, Michael AU - Bilous M AD - Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead, New South Wales, Australia. FAU - Dowsett, Mitch AU - Dowsett M FAU - Hanna, Wedad AU - Hanna W FAU - Isola, Jorma AU - Isola J FAU - Lebeau, Annette AU - Lebeau A FAU - Moreno, Aberlardo AU - Moreno A FAU - Penault-Llorca, Frederique AU - Penault-Llorca F FAU - Ruschoff, Josef AU - Ruschoff J FAU - Tomasic, Gorana AU - Tomasic G FAU - van de Vijver, Marc AU - van de Vijver M LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review PL - United States TA - Mod Pathol JT - Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc JID - 8806605 RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Algorithms MH - Breast Neoplasms/*diagnosis/*genetics MH - Genetic Testing/*standards MH - *Health Planning Guidelines MH - Histocytological Preparation Techniques/methods/standards MH - Humans MH - Immunohistochemistry/methods/standards MH - In Situ Hybridization, Fluorescence MH - Quality Control MH - Receptor, ErbB-2/*genetics RF - 66 EDAT- 2003/02/20 04:00 MHDA- 2003/08/06 05:00 CRDT- 2003/02/20 04:00 PHST- 2003/02/20 04:00 [pubmed] PHST- 2003/08/06 05:00 [medline] PHST- 2003/02/20 04:00 [entrez] AID - 10.1097/01.MP.0000052102.90815.82 [doi] PST - ppublish SO - Mod Pathol. 2003 Feb;16(2):173-82. doi: 10.1097/01.MP.0000052102.90815.82.