Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)
Closed Posted
- Opportunity number
- PAR-24-304
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
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- Health
- Education
- Eligible applicants
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- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- Non-501(c)(3) Nonprofits
- Public or Indian Housing Auth.
- Small Businesses
- Higher Education Inst. (Public)
- Higher Education Inst. (Private)
- Other
- State Governments
- Tribal Governments (Federally Recognized)
- Special District Governments
- For Profit Organizations
- Independent School Districts
- County Governments
- 501(c)(3) Nonprofits
- Points of contact
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- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health National Cancer Institute is soliciting revision applications for validation of biomarker assays developed through NIH-supported research, with an application deadline of October 14, 2026. This opportunity does not support clinical trials and is limited to adaption and clinical validation of molecular, cellular, and imaging markers for cancer detection, diagnosis, prognosis, monitoring, and treatment response prediction.
Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), small businesses, for-profit organizations, state and local governments, tribal organizations and governments, special district governments, independent school districts, housing authorities, Alaska Native and Native Hawaiian Serving Institutions, HBCUs, Hispanic-serving Institutions, AANAPISIs, TCCUs, faith-based and community-based organizations, regional organizations, federally recognized and other Indian tribal governments, eligible federal agencies, non-domestic entities, and U.S. territories.
Applications may support acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts and consortia for clinical validation purposes. The program encourages multidisciplinary teams including assay developers, clinicians, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage technology development but rather adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays, tools, or devices.
Funding falls under CFDA 93.394, Cancer Detection and Diagnosis Research. Evaluation emphasizes scientific merit, technical adequacy of experimental design, investigator competency, facility adequacy, budget necessity, and program relevance. Awards are made annually based on scientific merit, program relevance, and program balance consistent with NCI and NIH priorities. Financial records must be retained for three years from submission of the final financial status report.
Synopsis
Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.
Eligibility
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Files
| File | Type | Posted |
|---|---|---|
| PAR-24-304-Full-Announcement.html | HTML file | |
| PKG00288402.pdf |
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