Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research

The National Institutes of Health is seeking applications for a consortium to advance the systematic identification, rigorous evaluation, validation, and assays harmonization of biomarkers that are critical to the prevention, diagnosis, and clinical management of Type 1 Diabetes. The consortium will leverage state-of-the-art methodologies in clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging, coupled with longitudinal patient cohorts and mining of Electronic Health Records. The key objectives of this initiative include: • Harmonizing established assays for biomarkers such as HbA1c and c-peptide • Identifying and validating other biomarkers that can be used for the prevention, diagnosis, and clinical management of Type 1 Diabetes • Ensuring that all assays for biomarkers are rigorously validated and assessed for reproducibility across several laboratories The estimated funding for this initiative is $5,200,000, and the estimated award date is April 1, 2027.