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Updated: Nov 15, 2025
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Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
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Predictive biomarkers and clinical evidence
1Dx-Rx Institute, Fredensborg, Denmark.
Basic & Clinical Pharmacology & Toxicology
|March 5, 2021
Summary
Predictive biomarkers can personalize drug therapy, but robust clinical evidence is crucial for their safe and effective use. Regulatory bodies like the FDA and EU are emphasizing biomarker assay validity to ensure patient safety.
Area of Science:
- Pharmacogenomics and Personalized Medicine
- Biomarker Assay Development and Validation
- Regulatory Science in Healthcare
Background:
- Predictive biomarkers are increasingly used to tailor pharmacotherapy, aiming to optimize drug efficacy and minimize adverse events.
- Current evidence supporting the clinical utility of many predictive biomarker assays is often insufficient for guiding prescribing decisions.
- The integration of biomarkers into clinical practice necessitates rigorous validation to ensure patient safety and treatment effectiveness.
Purpose of the Study:
- To highlight the critical need for robust scientific and clinical evidence when utilizing predictive biomarkers in pharmacotherapy.
- To emphasize the role of regulatory authorities in ensuring the validity and safety of biomarker assays.
- To underscore the importance of analytical and clinical validity for biomarker assays, particularly with evolving regulations.
Main Methods:
- Review of current practices and regulatory frameworks for predictive biomarker assays.
- Discussion of the scientific and clinical evidence requirements for pharmacogenetic and tumor profiling tests.
- Analysis of regulatory approaches by agencies such as the FDA and the implications of new EU IVD regulations.
Main Results:
- Many predictive biomarker assays lack sufficient evidence to support their routine use in clinical decision-making.
- Regulatory bodies are actively establishing frameworks (e.g., companion diagnostics approval) to ensure biomarker assay validity.
- Upcoming regulations in the EU will further scrutinize the analytical and clinical validity of in vitro diagnostic (IVD) biomarker assays.
Conclusions:
- Decisions based on predictive biomarkers must be supported by solid clinical evidence to ensure patient safety.
- The scientific and analytical validity of biomarker assays is paramount, with regulatory oversight playing a key role.
- Comprehensive clinical evidence is essential before the routine implementation of any predictive biomarker assay in healthcare settings.
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