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Upcoming NIDDK Funding Opportunity: Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research

Here is the information from grants.gov:

"RFA-DK-27-140

Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research
Department of Health and Human Services
National Institutes of Health
Note: This is a Forecasted Opportunity.

Description
The main goal of this initiative is to establish a consortium with the overarching goal 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 (T1D). Despite significant advances in T1D research, there remains an urgent need for reliable and reproducible biomarkers that can capture the complexity of autoimmune processes, metabolic dysregulation, and individual patient variability. This initiative 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 (EHR). Within this consortium major efforts will be devoted to: 1) Harmonize established assays for biomarkers such as HbA1c and c-peptide, making sure that these assays are performed in a rigorous and reproducible manner in the clinical research community and in clinical practice. For this purpose, reference methods and materials will use a metrology approach and will be made available to the community; 2) Identify and validate other biomarkers that can be used for the prevention, diagnosis, and clinical management of T1D. It has been reported that the assays for several biomarkers routinely used in clinical research such as glucagon, amylin, chromogranin, insulin, pro-insulin and other pro-hormones are not reproducible across platforms or laboratories. For this purpose, this consortium will ensure that all assays for biomarkers routinely used in clinical research and for newly identified biomarkers are rigorously validated and assessed for reproducibility across several laboratories following a metrology approach.
Estimated Post Date:Apr 01, 2026
Estimated Application Due Date:Jun 25, 2026
Estimated Award Date:Apr 01, 2027
Estimated Project Start Date:May 01, 2027
Fiscal Year:2027
Archive Date:
Estimated Total Program Funding:$ 5,200,000

Eligible Applicants:Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
Special district governments
Independent school districts
State governments
Public and State controlled institutions of higher education
Small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
For profit organizations other than small businesses
Native American tribal governments (Federally recognized)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
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Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
County governments
Special district governments
Ind
...[more]
Additional Information on Eligibility:Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions). [less] [less] [less]Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Co ...[more]
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Grantor Contact Information:
Division of Diabetes, Endocrinology and Metabolic Diseases




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