New Publication in Bioanalysis

Immunogenicity testing has operated under the same 3-tiered paradigm for over two decades. A new perspective from our Chief Scientific Officer, Dr. Lauren Stevenson, asks whether that framework is still fit for purpose.

Published this week in Bioanalysis, Lauren’s paper presents a reanalysis of ADA data from a Phase 1 monoclonal antibody study, applying a biomarker-oriented approach that goes beyond binary positive/negative classifications.

By incorporating full signal distributions, S/N ratios, placebo controls, and longitudinal variability, the analysis:
➡️ Clarifies apparent baseline positivity
➡️ Distinguishes true treatment-emergent responses from biological noise
➡️ Reveals subjects classified as ADA-positive who reflect low-level, clinically irrelevant variability
➡️ Demonstrates that continuous readouts provide richer interpretation than titers alone

The findings raise important questions about incidence inflation, clinical context, and program risk characterization under the current methodology.

This is the kind of analysis that changes how teams approach immunogenicity data. Not by adding assay tiers, but by asking better questions of existing data.

Read the full paper in Bioanalysis: https://www.tandfonline.com/doi/full/10.1080/17576180.2026.2677736#abstract