Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- PAR-28-042
- 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
- Category
-
- Health
- Eligible applicants
-
- Higher Education Inst. (Private)
- Tribal Governments (Federally Recognized)
- Small Businesses
- City/Township Governments
- State Governments
- 501(c)(3) Nonprofits
- Public or Indian Housing Auth.
- Non-501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- Higher Education Inst. (Public)
- Independent School Districts
- Special District Governments
- County Governments
- For Profit Organizations
- Other
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Cancer Institute, part of the National Institutes of Health, is soliciting cooperative agreement applications to validate molecular, cellular, and imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of treatment response or resistance, with a listed due date of November 16, 2029. The title specifies "Clinical Trial Not Allowed" for the UH2/UH3 mechanism. The attached NOFO summary gives no application due date, so verify the listed date against the full announcement.
Eligible applicants include private and public higher education institutions, federally recognized tribal governments, tribal organizations not federally recognized, small businesses, for-profit organizations, 501(c)(3) and non-501(c)(3) nonprofits, state, county, and city/township governments, public housing authorities, independent school districts, special district governments, faith-based or community-based organizations, regional organizations, U.S. territories, and federal agencies. Foreign organizations and non-domestic components of U.S. organizations are ineligible, but foreign components are allowed.
Applicants choose either a biphasic UH2/UH3 application for five years or a standalone UH3 application for three years. The UH2 phase funds analytical validation, which must be achieved within two years before clinical validation begins. The UH3 phase supports clinical validation for up to three years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. UH2/UH3 applicants must address both phases and propose transition milestones, while standalone UH3 applicants must already hold analytically validated assays. The NOFO also supports pharmacodynamic markers and markers of toxicity, and multiple markers, including immune markers, can be developed and validated simultaneously.
Reviewers assess scientific merit and significance, technical adequacy of design, investigator competency, facilities and resources, budget necessity, and relevance to program objectives. The source does not assign weights to these criteria. Awards are made annually based on scientific merit, program relevance, and program balance.
The opportunity operates under Assistance Listing 93.394, Cancer Detection and Diagnosis Research, and is also assigned to 93.CA1, National Cancer Institute Research - Research Projects. The parent program recorded 185 awards in 2026 through September, following 158 in 2025 and 270 in 2022, with recent awards ranging from $232 thousand to $1.5 million.
Synopsis
The purpose of the Notice of Funding Opportunity (NOFO) is to support the analytical and clinical validation of molecular, cellular, and imaging biomarkers and assays for cancer detection, diagnosis, prognosis, monitoring, prediction of response or resistance to treatment, cancer prevention and control, as well as pharmacodynamic markers and markers of toxicity. Utilizing either a phased UH2/UH3 or a standalone UH3 mechanism, funding will facilitate laboratory optimization and clinical validation of assays that work on human samples and address a clearly defined cancer-related clinical need within a well-specified intended use.
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations: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 |
|---|---|---|
| PKG00294510.pdf | ||
| PAR-28-042-Full-Announcement.html | HTML file |
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