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From tiers to truth - a biomarker-based framework for clinically relevant immunogenicity assessment
1Translational Sciences, Immunologix Laboratories, Tampa, FL, USA.
Bioanalysis
|May 15, 2026
Summary
Immunogenicity testing for biotherapeutics needs a context-driven approach. Reframing anti-drug antibody (ADA) assays using continuous data improves clinical relevance and patient outcomes.
Area of Science:
- Biomarker Discovery and Development
- Pharmacology and Drug Development
- Immunology and Translational Medicine
Background:
- Immunogenicity, a biological response to therapeutics, is a biomarker.
- Current anti-drug antibody (ADA) testing uses a uniform, three-tiered paradigm.
- This paradigm, based on cut points and titer reporting, may not align with drug development needs.
Purpose of the Study:
- To argue for a context-of-use-driven approach to immunogenicity biomarker measurement.
- To highlight limitations of current ADA testing paradigms.
- To propose a reframing of immunogenicity assays for improved clinical interpretation.
Main Methods:
- Perspective piece analyzing current immunogenicity testing methodologies.
- Discussion of limitations in titer-based readouts and binary classifications.
- Advocacy for leveraging continuous response profiles and PK/PD data.
Main Results:
- Current immunogenicity datasets often lose biological context and inflate incidence rates.
- Titer-based readouts may lack granularity for contemporary biotherapeutics.
- A reframed approach can preserve nuance and improve interpretability.
Conclusions:
- Reframing immunogenicity as a context-of-use biomarker enhances clinical relevance.
- Continuous response profiles integrated with PK/PD data identify meaningful thresholds.
- This approach improves stakeholder communication and focuses on patient-relevant clinical impact.
