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Methodological requirements for valid tissue-based biomarker studies that can be used in clinical practice
1Department of Pathology, University of Washington Medical Center, 1959 NE Pacific St., Box 356100, Seattle, WA, USA, ltrue@u.washington.edu.
Virchows Archiv : an International Journal of Pathology
|February 4, 2014
Summary
This review examines how sample and assay variables affect tissue-based biomarker testing for cancer. Understanding these factors is crucial for accurate clinical decision-making using molecular biomarkers.
Area of Science:
- Biomarker discovery and validation
- Molecular pathology
- Cancer diagnostics
Background:
- Advancements in genomic sequencing have identified numerous cancer-related molecular abnormalities.
- These abnormalities are translated into clinical assays for decision-making.
- Assay results are influenced by sample characteristics, assay specifics, and interpretation.
Purpose of the Study:
- To review the impact of preanalytical and analytical variables on tissue-based biomarker assays.
- To classify these variables by macromolecule (DNA, RNA, protein).
- To focus on protein biomarkers due to their prevalence in immunohistochemistry.
Main Methods:
- Discussion of preanalytical variables: analyte stability, ischemia time, fixation, processing, storage.
- Analysis of assay variables: reagent specificity, technical components, quantitation, interpretation.
- Reference to guidelines for biomarker development and clinical use.
Main Results:
- Preanalytical variables significantly impact biomarker assay results.
- Assay-specific factors, including reagent specificity and quantitation, are critical.
- The appropriateness of an assay for clinical application is a key consideration.
Conclusions:
- Variability in sample handling and assay execution affects biomarker reliability.
- Standardization and adherence to guidelines are essential for robust biomarker assays.
- Improving biomarker reporting quality is vital for clinical utility.
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