Garbage in, garbage out: A critical evaluation of strategies used for validation of immunohistochemical biomarkers. Issue 4 (21st March 2014)

• Record Type: Journal Article
• Authors: O'Hurley, Gillian; Sjöstedt, Evelina; Rahman, Arman; Li, Bo; Kampf, Caroline; Pontén, Fredrik; Gallagher, William M.; Lindskog, Cecilia
• Other Names: Spatz Alan specialEditor.; van Kempen Léon specialEditor.
• Is Part Of: Molecular oncology. Volume 8:Issue 4(2014:Jun.)
• Page Start: 783
• Page End: 798
• Publication Date: 2014-03-21
• Subjects: Immunohistochemistry -- Biomarker discovery -- Antibody reliability -- Antibody validation -- Workflow; Cancer -- Molecular aspects -- Periodicals; 616.994005
• DOI: 10.1016/j.molonc.2014.03.008
• Languages: English
• ISSNs: 1574-7891

Abstract

Abstract : The use of immunohistochemistry (IHC) in clinical cohorts is of paramount importance in determining the utility of a biomarker in clinical practice. A major bottleneck in translating a biomarker from bench‐to‐bedside is the lack of well characterized, specific antibodies suitable for IHC. Despite the widespread use of IHC as a biomarker validation tool, no universally accepted standardization guidelines have been developed to determine the applicability of particular antibodies for IHC prior to its use. In this review, we discuss the technical challenges faced by the use of immunohistochemical biomarkers and rigorously explore classical and emerging antibody validation technologies. Based on our review of these technologies, we provide strict criteria for the pragmatic validation of antibodies for use in immunohistochemical assays. Highlights: Immunohistochemistry is an important tool for biomarker development. Few potential immunohistochemistry biomarkers reach the clinical utility. We describe the various factors influencing the IHC process. We discuss classical and emerging antibody validation technologies. We provide recommended work‐flows for proper antibody validation.