title: Analysis of protein biomarkers in human clinical tumor samples: critical aspects to success from tissue acquisition to analysis.
abstract: There has been increased interest in the analysis of protein biomarkers in clinical tumor tissues in recent years. Tissue-based biomarker assays can add value and aid decision-making at all stages of drug development, as well as being developed for use as predictive biomarkers and for patient stratification and prognostication in the clinic. However, there must be an awareness of the legal and ethical issues related to the sourcing of human tissue samples. This article also discusses the limits of scope and critical aspects on the successful use of the following tissue-based methods: immunohistochemistry, tissue microarrays and automated image analysis. Future advances in standardization of tissue biobanking methods, immunohistochemistry and quantitative image analysis techniques are also discussed.
authors.affiliation: Pathology Diagnostics Ltd, St John's Innovation Centre, Cowley Road, Cambridge, CB4 0WS, UK. mvw@pathologydiagnostics.com
authors.forename: Madhuri V
authors.initials: MV
authors.lastname: Warren
authors.forename: W Y Iris
authors.initials: WY
authors.lastname: Chan
authors.forename: John M
authors.initials: JM
authors.lastname: Ridley
mesh_terms: D001331:Automation; D014408:Biomarkers, Tumor / Q000032:analysis*; D002986:Clinical Trials as Topic; D003952:Diagnostic Imaging; D005062:European Union; D006801:Humans; D007150:Immunohistochemistry; D009363:Neoplasm Proteins / Q000032:analysis*; D009926:Organ Preservation; D046888:Tissue Array Analysis; D020858:Tissue and Organ Harvesting / Q000941:ethics / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States
chemical_list: D014408:Biomarkers, Tumor; D009363:Neoplasm Proteins