title: Standardizing slide-based assays in breast cancer: hormone receptors, HER2, and sentinel lymph nodes.
abstract: Despite the rapid expansion of novel diagnostics designed to personalize breast cancer care, there remain several significant unmet needs for improving the accuracy and reliability of tests that are already in common daily clinical practice. For example, although immunohistochemistry has been the predominant method for measuring estrogen receptor and progesterone receptor status for over 15 years, this assay remains unstandardized and there is a widespread concern that inaccuracy in immunohistochemistry technique and interpretation is leading to an unacceptably high error rate in determining the true hormone receptor status. Similarly, there is considerable concern that both false-negative and false-positive result rates for testing for HER2 status are unacceptably high in current clinical practice. This commentary considers a variety of factors, including preanalytic conditions and slide-scoring procedures, and other variables that may be contributing to current testing error rates and why there is a great need for the standardization of these biomarker assay procedures to further enable the highest possible quality of care for newly diagnosed breast cancer patients.
authors.affiliation: Department of Pathology and Laboratory Medicine, Albany Medical College, Albany, New York 12208, USA. rossj@mail.amc.edu
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Ross
authors.forename: W Fraser
authors.initials: WF
authors.lastname: Symmans
authors.forename: Lajos
authors.initials: L
authors.lastname: Pusztai
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis* / Q000473:pathology; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007150:Immunohistochemistry / Q000592:standards*; D017403:In Situ Hybridization; D008198:Lymph Nodes / Q000737:chemistry; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D011960:Receptors, Estrogen / Q000032:analysis*; D011980:Receptors, Progesterone / Q000032:analysis*; D021701:Sentinel Lymph Node Biopsy
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone