Grants.gov listing

Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research

National Institutes of HealthFederal GrantSolicitation RFA-DK-27-140

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Opportunity details

Notice type
Federal Grant
Original posted
February 4, 2026
Last updated
October 18, 2026
Notice ID
grant-361235

Summary

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.

Read Full Official Summary

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.

Summary fields are from official SAM.gov or Grants.gov structured data. CaptureIQ does not republish full solicitation or grant text.

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).

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).

Eligible applicant categories

  • State governments
  • County governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)

Official Grants.gov eligibility information. Listed categories are not a determination that an organization qualifies.

Funding and program

Assistance Listing
93.847
Funding instrument
G
Cost sharing
Not required
Estimated total program funding
$5,200,000
Expected number of awards
8 (government estimate, not a guaranteed count)
Official modification date

Estimated total program funding is the government figure for the whole program, not an individual award ceiling. The expected number of awards is a government estimate, not a guaranteed count. These figures are estimates, not guaranteed funding.

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