One for the Win: Singlicate Analysis for Diverse Therapeutic Modalities

This talk evaluates singlicate ADA analysis which could improve efficiency without compromising data integrity. In 2024, Regeneron’s bioanalytical labs analyzed ~20,000 samples in duplicate; < 0.05% had %CV >20%, demonstrating strong ADA method consistency across modalities. Retrospective analyses of assay validations and 3-tier clinical data from four therapeutics (siRNA, bsAbs, and soluble receptor) confirmed that singlicate analysis maintained >90% sample disposition concordance with duplicate testing and did not meaningfully change participant immunogenicity rates or status. Recalculating screening cutpoints based on singlicate validation data minimally affected cutpoint values and immunogenicity calls. Additional parameters were considered including assessment of variability sources (%CV values, run variance).
These multi-modality case studies support adoption and development of singlicate ADA assays. This presentation reflects the author’s views; any implication that singlicate ADA analysis should be accepted by the FDA is not endorsed by Regeneron.