Publication with Bioanalysis

The three-tier ADA paradigm wasn’t built from first principles. It was built from caution.

That’s the central argument in a new perspective piece by Immunologix Laboratories Chief Scientific Officer, Dr. Lauren Stevenson, who just published in Bioanalysis: “From Tiers to Truth — A Biomarker-Based Framework for Clinically Relevant Immunogenicity Assessment.”

Lauren’s paper argues that immunogenicity is, by definition, a biomarker. Yet ADA testing has evolved differently from every other biomarker discipline. Rather than tailoring analytical performance to the context of use, the field converged on a uniform, three-tiered system anchored to statistical cut points and titer reporting. The result: binary classifications that can inflate incidence, discard biological context, and make it harder to connect immune responses to outcomes that actually matter: PK, PD, efficacy, safety.

The proposed reframe is methodologically and conceptually significant. Treat immunogenicity as a context-of-use-driven biomarker measurement. Use continuous response profiles alongside PK/PD and clinical data to establish thresholds that reflect clinical relevance rather than statistical convention.

Congratulations, Lauren, on this publication!

Read the full article: https://www.tandfonline.com/doi/full/10.1080/17576180.2026.2672455