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Updated: May 31, 2026
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Multimodal Analytical Platform on a Multiplexed Surface Plasmon Resonance Imaging Chip for the Analysis of Extracellular Vesicle Subsets
Published on: March 17, 2023
Extracellular Vesicles as Enabling Biomarkers for New Approach Methodologies to Support the US Food and Drug
Andrew Rowland1, Carl Kirkpatrick2, A David Rodrigues3
1College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Journal of Extracellular Vesicles
|May 28, 2026
Summary
The FDA Modernization Act 3.0 allows New Approach Methodologies (NAMs) by removing animal testing requirements. Extracellular vesicles (EVs) offer promising human-relevant biomarkers to support NAMs in regulatory decision-making for drug development.
Area of Science:
- Biomedical Research
- Regulatory Science
- Biomarker Discovery
Background:
- The FDA Modernization Act 3.0 shifts biomedical research away from animal testing towards New Approach Methodologies (NAMs).
- This regulatory change necessitates human-relevant biomarkers for validating NAM-generated data in drug development.
- Extracellular vesicles (EVs) possess unique properties making them suitable for this role.
Purpose of the Study:
- To outline the potential of Extracellular Vesicles (EVs) as biomarkers for the regulatory acceptance of NAMs.
- To emphasize the utility of EVs in supporting first-in-human studies and regulatory decision-making.
- To highlight the integration of EV biomarkers with advanced human-derived model systems.
Main Methods:
- Review and perspective on the application of EVs in regulatory science.
- Focus on ex vivo platforms like organoids, microtissues, organ-on-chip, and perfused tissues.
- Integration of EV data with quantitative systems pharmacology and physiologically based pharmacokinetic models.
Main Results:
- EVs are stable, accessible, and contain rich molecular cargo reflecting cellular states and communication.
- EVs provide mechanistically informative readouts for pharmacology, toxicity, and disease biology.
- Advantages include longitudinal sampling, human variability representation, and model system integration.
Conclusions:
- EV-based biomarkers can support the qualification, standardization, and regulatory acceptance of NAMs.
- Addressing scientific, operational, and regulatory challenges is crucial for widespread adoption.
- Coordinated leadership is essential to establish EVs as foundational biomarkers in human-centric drug development.
