No. PAR-25-074 · National Institutes of Health
Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
- Award range
- Not specified
- Expected awards
- Not specified
- Application deadline
- Oct 14, 2026
- Posted
- Oct 15, 2024
- Last verified
- 2 days ago
At a glance
AI summaryThis program funds analytical and clinical validation of existing molecular, cellular, and in vitro imaging assays and biomarkers for cancer detection, diagnosis, prognosis, monitoring, treatment response, prevention, and control. It is for investigator-initiated projects using human specimens, and applications must cover both the UH2 analytical validation phase and the UH3 clinical validation phase; clinical trials are not allowed. Eligible applicants include many U.S. institutions, nonprofits, governments, tribes, for-profits, and small businesses, but foreign organizations and non-domestic U.S. components are not eligible. Applicants may request up to $275,000 in direct costs for the full UH2 phase, with no more than $200,000 in any one year, and up to $250,000 in direct costs per year for UH3; no cost sharing is required.
AI-generated summary — verify against the announcement
What it funds
Official description from grants.gov
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.
Who can apply
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized)
- Nonprofits with 501(c)(3) status (other than higher education)
- Nonprofits without 501(c)(3) status (other than higher education)
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities / Indian housing authorities
- Small businesses
- Special district governments
- State governments
Program history
USASpending.govAssistance listing 93.394 · Cancer Detection and Diagnosis Research
Real awards this federal program has made — the whole assistance listing (93.394), not just this notice.
| Fiscal year | Awards | Median award | Middle half |
|---|---|---|---|
| FY 2026 (so far) | 137 | $595,012 | $414,585 – $662,610 |
| FY 2025 | 184 | $726,875 | $399,923 – $1,297,708 |
| FY 2024 | 215 | $1,129,641 | $414,953 – $1,862,878 |
| FY 2023 | 268 | $1,754,736 | $438,924 – $2,398,100 |
| FY 2022 | 277 | $2,036,627 | $596,368 – $3,077,027 |
| FY 2021 | 269 | — | — |
Dollar figures are based on the 1,000 most recent awards we store, not all 1,350 — award counts are complete.
- TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE $8,347,015 · FY 2022
- BATTELLE MEMORIAL INSTITUTE $6,630,183 · FY 2022
- THE JOHNS HOPKINS UNIVERSITY $6,618,085 · FY 2022
- SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH $6,181,895 · FY 2022
- OREGON HEALTH & SCIENCE UNIVERSITY $5,771,926 · FY 2022
Source: USASpending.gov · refreshed Aug 14, 2026