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A matrix approach to guide IHC ‐based tissue biomarker development in oncology drug discovery
Author(s) -
Smith Neil R,
Womack Christopher
Publication year - 2014
Publication title -
the journal of pathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.964
H-Index - 184
eISSN - 1096-9896
pISSN - 0022-3417
DOI - 10.1002/path.4262
Subject(s) - biomarker , immunohistochemistry , drug development , companion diagnostic , biomarker discovery , medicine , drug discovery , matrix (chemical analysis) , oncology , drug , pathology , computational biology , bioinformatics , biology , cancer , chemistry , pharmacology , proteomics , biochemistry , chromatography , gene
Abstract Immunohistochemistry ( IHC ) is a core platform for the analysis of tissue samples, and there is an increasing demand for reliable and quantitative IHC ‐based tissue biomarkers in oncology clinical research and development (R&D) environments. Biomarker assay and drug development proceed in parallel. Furthermore, biomarker assay requirements change with each phase of drug development. We have therefore developed a matrix tool to enable researchers to evaluate whether a particular IHC biomarker assay is fit for purpose. Experience gained from the development of 130 IHC biomarkers, supporting a large number of oncology drug projects, was used to formulate a practical approach to IHC assay development. The resultant matrix grid and accompanying work flow incorporates 16 core decision points that link antibody and assay specificity and sensitivity, and assay performance in preclinical and clinical samples, with stages of drug development. The matrix provides a means to ensure that relevant information on an IHC assay in development is recorded and communicated consistently and that minimum assay validation requirements are met. Copyright © 2013 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.