The Use of Immunohistochemistry for Biomarker Assessment—Can It Compete with Other Technologies?

A morphology-based assay such as immunohistochemistry (IHC) should be a highly effective means to define the expression of a target molecule of interest, especially if the target is a protein. However, over the past decade, IHC as a platform for biomarkers has been challenged by more quantitative mo...

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Bibliographic Details
Published in:Toxicologic Pathology 2011-10, Vol.39 (6), p.988-1002
Main Authors: Dunstan, Robert W., Wharton, Keith A., Quigley, Catherine, Lowe, Amanda
Format: Article
Language:English
Subjects:
Animals
Biological and medical sciences
Biomarkers - analysis
Gene Expression - physiology
Histocytological Preparation Techniques
Humans
Image Processing, Computer-Assisted - methods
Immunohistochemistry - methods
Immunohistochemistry - standards
Medical sciences
Microscopy
Reference Standards
Reproducibility of Results
Toxicology
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Summary:A morphology-based assay such as immunohistochemistry (IHC) should be a highly effective means to define the expression of a target molecule of interest, especially if the target is a protein. However, over the past decade, IHC as a platform for biomarkers has been challenged by more quantitative molecular assays with reference standards but that lack morphologic context. For IHC to be considered a “top-tier” biomarker assay, it must provide truly quantitative data on par with non-morphologic assays, which means it needs to be run with reference standards. However, creating such standards for IHC will require optimizing all aspects of tissue collection, fixation, section thickness, morphologic criteria for assessment, staining processes, digitization of images, and image analysis. This will also require anatomic pathology to evolve from a discipline that is descriptive to one that is quantitative. A major step in this transformation will be replacing traditional ocular microscopes with computer monitors and whole slide images, for without digitization, there can be no accurate quantitation; without quantitation, there can be no standardization; and without standardization, the value of morphology-based IHC assays will not be realized.
ISSN:0192-6233
1533-1601
DOI:10.1177/0192623311419163