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The use of immunohistochemistry for biomarker assessment--can it compete with other technologies?
Robert W Dunstan1, Keith A Wharton, Catherine Quigley
1Biogen Idec, Cambridge, Massachusetts 02142, USA. bob.dunstan@biogenidec.com
Insights
To enhance immunohistochemistry (IHC) as a top-tier biomarker assay, quantitative data and reference standards are crucial. This requires optimizing tissue handling, staining, digitization, and image analysis for reliable morphologic context.
Area of Science:
- Biomarker Assay Development
- Anatomic Pathology
- Digital Pathology
Background:
- Immunohistochemistry (IHC) offers valuable morphologic context for protein expression but faces challenges from quantitative molecular assays.
- Current IHC lacks reference standards, hindering its classification as a top-tier biomarker assay.
- Achieving true quantitation in IHC is essential to match the rigor of non-morphologic assays.
Purpose of the Study:
- To outline the necessary steps for transforming IHC into a quantitative, standardized biomarker assay.
- To emphasize the critical role of reference standards in validating IHC results.
- To highlight the integration of digital pathology tools for accurate IHC assessment.
Main Methods:
- Optimizing tissue collection, fixation, and section thickness.
- Standardizing staining processes and developing morphologic criteria for assessment.
- Implementing image digitization and advanced image analysis techniques.
Main Results:
- The study proposes a comprehensive framework for IHC standardization.
- Digitization and quantitative image analysis are identified as key enablers.
- The transition from descriptive to quantitative anatomic pathology is advocated.
Conclusions:
- Standardization through reference standards is paramount for realizing the full potential of morphology-based IHC assays.
- Adoption of digital pathology and quantitative analysis is essential for IHC's advancement.
- Optimized IHC assays will provide reliable, quantitative data, enhancing their value in diagnostics and research.
Abstract:
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.
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