Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Closed Posted
- Opportunity number
- PAR-25-075
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $250,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Education
- Health
- Eligible applicants
-
- Other
- City/Township Governments
- 501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- Special District Governments
- Non-501(c)(3) Nonprofits
- Higher Education Inst. (Private)
- Public or Indian Housing Auth.
- Tribal Governments (Federally Recognized)
- State Governments
- County Governments
- Small Businesses
- Independent School Districts
- Higher Education Inst. (Public)
- For Profit Organizations
- 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 is soliciting applications through a cooperative agreement to fund clinical validation of analytically validated molecular, cellular, and imaging biomarker assays for cancer detection, diagnosis, prognosis, monitoring, treatment response prediction, and prevention, with applications due October 14, 2026. The UH3 mechanism explicitly does not support early-stage technology development or the conduct of clinical trials; applicants must have assays whose analytical performance has been validated in specimens similar to those intended for clinical use, and this funding will support clinical validation for up to three years using specimens from retrospective or prospective clinical trials or studies.
Eligible applicant categories include higher education institutions (public and private), small businesses, city and township governments, state and county governments, nonprofit organizations (501(c)(3) and non-501(c)(3)), tribal governments (federally recognized and other), for-profit organizations, independent school districts, public or Indian housing authorities, special district governments, and other entities including HBCUs, Hispanic-serving institutions, AANAPISIs, and TCCUs. Non-domestic entities and non-domestic components of U.S. organizations are ineligible; however, foreign components as defined in the NIH Grants Policy Statement are permitted.
Projects must demonstrate multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. The NOFO supports validation of assays for use in clinical trials, observational studies, population studies, and harmonization efforts to assess assay performance and reproducibility across multiple clinical laboratories. Assays measuring multiple markers, including immune markers, may be developed and validated simultaneously, particularly in combination with chemotherapy, radiation therapy, and immunotherapy approaches.
The funding falls under CFDA 93.394 (Cancer Detection and Diagnosis Research). The source does not specify award ceiling, award floor, expected number of awards, period of performance, place of performance, cost share requirements, or detailed evaluation criteria specific to this NOFO.
Synopsis
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and 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 NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). 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 UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other 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 interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.
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-25-075-Full-Announcement.html | HTML file | |
| PKG00288411.pdf |
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