Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
Closed Posted
- Opportunity number
- PAR-25-074
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
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- Education
- Health
- Eligible applicants
-
- For Profit Organizations
- Small Businesses
- 501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- County Governments
- State Governments
- Non-501(c)(3) Nonprofits
- Independent School Districts
- Tribal Governments (Federally Recognized)
- Tribal Organizations (Not Federally Recognized)
- Other
- City/Township Governments
- Public or Indian Housing Auth.
- Higher Education Inst. (Public)
- Special District Governments
- 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 Cancer Institute seeks applicants to support validation of molecular, cellular, and imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, prediction of treatment response or resistance, and cancer prevention and control, with applications due October 14, 2026.
Eligible applicants include for-profit organizations, small businesses, 501(c)(3) nonprofits, higher education institutions (public and private), state and local governments, tribal governments and organizations, independent school districts, and other entity types. Non-domestic (non-U.S.) entities are not eligible to apply, though foreign components as defined in the NIH Grants Policy Statement are allowed within U.S. organizations.
The opportunity funds two phases through cooperative agreement. The UH2 phase supports analytical validation of assays for molecular, cellular, or imaging markers, which must be completed within 2 years before clinical validation. The UH3 phase supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. Applicants should propose assays already working on human samples with well-justified importance for development into clinical assays. Efforts to harmonize clinical laboratory tests across multiple laboratories and investigation of assay performance and reproducibility are appropriate. The program supports validation of pharmacodynamic markers and toxicity markers, and encourages simultaneous development of assays measuring multiple markers including immune markers as chemotherapy and radiation therapy increasingly combine with immunotherapies.
Projects must involve multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. The opportunity funds investigator-initiated research for analytical and clinical validation of assays for cancer treatment, control, or prevention trials supported by NCI.
Funding operates under CFDA 93.394 (Cancer Detection and Diagnosis Research).
Synopsis
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist.
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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-074-Full-Announcement.html | HTML file | |
| PKG00288410.pdf |
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