Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Can you apply?
This grant is for research institutions and organizations seeking to validate molecular, cellular, or imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, and treatment response prediction. Eligible applicants include universities, government agencies, faith-based organizations, HBCUs, tribal institutions, and regional organizations. Applicants must have analytically validated assays in appropriate specimens and will conduct clinical validation using retrospective or prospective data for up to 3 years. This is not for early-stage technology development or clinical trial conduct, but for validation of assays ready for integration into clinical research.
Program description
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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- HBCU
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project Narrative/Research Plan
- Budget and Budget Justification
- Biographical Sketches (all key personnel)
- Facilities and Resources
- Letters of Support/Collaboration
- Assay Validation Data (analytical validation evidence)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.394 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$67,679,289
-
$42,479,238
-
$38,139,324
-
$37,524,148
-
$36,939,788
-
$35,037,695
-
$30,393,940
-
$30,179,102
-
$18,143,614
-
$16,667,828
Top States by Funding
- PA 9 awards $127.6M
- WA 6 awards $109.7M
- CA 11 awards $101.7M
- TX 8 awards $91.8M
- OH 5 awards $73.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.394). How funding has trended year over year.
| 2024 | $540,918,671 | |
| 2025 | $602,293,691 | |
| 2026 est. | $716,748,079 |
FAQ
Who is eligible to apply for this grant?
Universities, government agencies, faith-based organizations, HBCUs, tribally controlled colleges, and regional organizations can apply. Non-domestic entities are not eligible. Your assay must already be analytically validated.
What type of work does this grant support?
Clinical validation of existing assays using retrospective or prospective specimens. Work harmonizing assays across multiple clinical laboratories is also eligible. Early-stage technology development and conducting clinical trials are not supported.
What is the project duration?
The UH3 mechanism supports validation efforts for up to 3 years. Multi-disciplinary teams with oncologists, statisticians, and lab scientists are required.
How much funding is available?
Award amounts start around $250,000, though amounts may vary. No cost-sharing is required from applicants.
When is the application deadline?
The deadline is October 14, 2026. This is a fixed deadline, not rolling.
💡 Tips for applicants
- Emphasize that your assay has already undergone analytical validation before applying. Reviewers expect this as a prerequisite for this funding mechanism.
- Assemble a multidisciplinary team that includes oncologists, statisticians, and clinical laboratory scientists. Single-discipline proposals are less competitive.
- Design validation studies using retrospective or prospective clinical data rather than proposing new clinical trial conduct. This aligns with the grant's intent.
- Clearly define which cancer markers (detection, prognosis, immune markers, toxicity) your validation will address and why clinical validation is necessary.
- Plan for multi-laboratory testing if harmonization across sites is feasible. This strengthens competitiveness and addresses a priority area.
⚠️ Common mistakes
Proposing early-stage assay development instead of validation of an already-analytected assay. Submitting without an assembled multidisciplinary team. Attempting to conduct a new clinical trial rather than using existing or readily-available clinical data for validation.
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