title: Evaluation of Candidate Biomarkers of Type 1 Diabetes via the Core for Assay Validation.
abstract: Recognizing an increasing need for biomarkers that predict clinical outcomes in type 1 diabetes (T1D), JDRF, a major funding organization for T1D research, recently instituted the Core for Assay Validation (CAV) to accelerate the translation of promising assays from discovery to clinical implementation via a process of coordinated evaluation of biomarkers. In this model, the CAV facilitates the validation of candidate assay methods as well as qualification of proposed biomarkers for a specific clinical use in well-characterized patients. We describe here a CAV-driven pilot project aimed at identifying biomarkers that predict the rate of decline in beta cell function after diagnosis. In a formalized pipeline, candidate assays are first assessed for general rationale, technical precision, and biological associations in a cross-sectional cohort. Those with the most favorable characteristics are then applied to placebo arm subjects of T1D intervention trials to assess their predictive correlation with beta cell function. We outline a go/no-go process for advancing candidate assays in a defined qualification pipeline that also allows for the discovery of novel predictive biomarker combinations. This strategy could be a model for other collaborative biomarker development efforts in and beyond T1D.
authors.affiliation: Diabetes Clinical Research Program, Benaroya Research Institute, Seattle, WA, USA.
authors.forename: Cate
authors.initials: C
authors.lastname: Speake
authors.affiliation: Diabetes Clinical Research Program, Benaroya Research Institute, Seattle, WA, USA.
authors.forename: Jared M
authors.initials: JM
authors.lastname: Odegard
keywords: C-peptide; assay qualification; assay validation; type 1 diabetes