Simpler Grants.gov #RFA-DK-27-140

NIH Grant: Consortium for Biomarker Rigor and Reproducibility in Type 1 Diabetes Research

This opportunity from the National Institutes of Health (NIH) seeks to establish a research consortium focused on improving the rigor and reproducibility of biomarker assays for Type 1 Diabetes (T1D) clinical research. - Government Buyer: - National Institutes of Health (NIH), Division of Diabetes, Endocrinology and Metabolic Diseases - Scope of Work: - Establish a consortium to systematically identify, evaluate, validate, and harmonize biomarker assays for T1D - Focus on harmonizing established assays for biomarkers such as HbA1c and c-peptide - Validate additional biomarkers including glucagon, amylin, chromogranin, insulin, pro-insulin, and other pro-hormones - Employ advanced methodologies: clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging - Leverage longitudinal patient cohorts and Electronic Health Records mining - Ensure reproducibility and reliability of biomarker assays across laboratories using a metrology approach - Products/Services Requested: - No specific commercial products or OEMs are named; this is a grant for research and development services - Main service: Consortium formation and operation for biomarker assay harmonization and validation - Unique Requirements: - Emphasis on assay harmonization and reproducibility across multiple laboratories - Use of advanced multi-omics and clinical data integration - Open to a wide range of eligible research organizations - No specific OEMs or vendors are mentioned, as this is a research grant opportunity.

Description

This initiative aims to establish a consortium to advance the identification, evaluation, validation, and harmonization of biomarkers critical to the prevention, diagnosis, and clinical management of Type 1 Diabetes (T1D). It focuses on harmonizing established assays such as HbA1c and c-peptide and validating other biomarkers used in clinical research to ensure reproducibility across laboratories. The consortium will leverage methodologies in clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging, along with longitudinal patient cohorts and Electronic Health Records mining. The goal is to improve the reliability of biomarkers capturing autoimmune processes, metabolic dysregulation, and patient variability in T1D.

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