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forecasted

Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research

National Institutes of Health · RFA-DK-27-140

Award range

See source for award amount

Deadline

Not specified

Eligible applicants

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

Geographic eligibility and all attachment-specific conditions require review of the original announcement.

Eligibility details

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).

Matching funds & resources

Source matching-funds field: Not Required.

Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.

About this opportunity

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.

Funding geography: Not specified — review source. A funder’s address does not establish eligibility.

Review original source ↗

Funding instrument: Grant. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.

Source fields and evidence

id: 361235
Source ↗ · id

opportunityNumber: RFA-DK-27-140
Source ↗ · opportunityNumber

opportunityTitle: Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research
Source ↗ · opportunityTitle

revision: 0
Source ↗ · revision

agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails

owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode

cfdas: [{"id":431871,"opportunityId":361235,"cfdaNumber":"93.847","programTitle":"Diabetes, Digestive, and Kidney Diseases Extramural Research"}]
Source ↗ · cfdas

forecastDesc: <p>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&nbsp;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.&nbsp;</p>
Source ↗ · forecastDesc

applicantTypes: [{"id":"00","description":"State governments"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"20","description":"Private institutions of higher education"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"04","description":"Special district governments"},{"id":"01","description":"County governments"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"05","description":"Independent school districts"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"23","description":"Small businesses"}]
Source ↗ · applicantTypes

applicantEligibilityDesc: 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).
Source ↗ · applicantEligibilityDesc

fundingInstruments: [{"id":"G","description":"Grant"}]
Source ↗ · fundingInstruments

fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: Feb 04, 2026 09:45:49 AM EST
Source ↗ · lastUpdatedDate

status: forecasted
Source ↗ · oppHits[id=361235].oppStatus

Source retrieved 10/15/2026 · Revision 0. Always confirm current requirements and dates with the funder. Structured source fields are checked; this is not a determination that every applicant qualifies.

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