Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers validating molecular, cellular, or imaging markers and assays for cancer detection, diagnosis, prognosis, and treatment monitoring. Eligible applicants include research institutions, universities (including HBCUs, Hispanic-serving institutions, and tribal colleges), hospitals, federal agencies, faith-based organizations, and tribal governments. Non-U.S. entities cannot apply, but foreign components of U.S. organizations are allowed. The UH2 phase supports analytical validation within 2 years; UH3 supports clinical validation up to 3 years using well-annotated biospecimens from clinical trials or studies.
Projects must involve multi-disciplinary teams including scientists, oncologists, statisticians, and clinical laboratory scientists. Applicants should have assays already developed and working on human samples. This funding supports validation for cancer treatment, prevention, control trials, and observational studies.
This grant is for researchers validating molecular, cellular, or imaging markers and assays for cancer detection, diagnosis, prognosis, and treatment monitoring. Eligible applicants include research institutions, universities (including HBCUs, Hispanic-serving institutions, and tribal colleges), hospitals, federal agencies, faith-based organizations, and tribal governments. Non-U.S. entities cannot apply, but foreign components of U.S. organizations are allowed. The UH2 phase supports analytical validation within 2 years; UH3 supports clinical validation up to 3 years using well-annotated biospecimens from clinical trials or studies.
Projects must involve multi-disciplinary teams including scientists, oncologists, statisticians, and clinical laboratory scientists. Applicants should have assays already developed and working on human samples. This funding supports validation for cancer treatment, prevention, control trials, and observational studies.
Program description
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
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Community Health Center
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers validating molecular, cellular, or imaging markers and assays for cancer detection, diagnosis, prognosis, and treatment monitoring. Eligible applicants include research institutions, universities (including HBCUs, Hispanic-serving institutions, and tribal colleges), hospitals, federal agencies, faith-based organizations, and tribal governments. Non-U.S. entities cannot apply, but foreign components of U.S. organizations are allowed. The UH2 phase supports analytical validation within 2 years; UH3 supports clinical validation up to 3 years using well-annotated biospecimens from clinical trials or studies.
Projects must involve multi-disciplinary teams including scientists, oncologists, statisticians, and clinical laboratory scientists. Applicants should have assays already developed and working on human samples. This funding supports validation for cancer treatment, prevention, control trials, and observational studies.
How to apply
Application links
Required documents
- SF-424 (R&R) Application Form
- Project Narrative/Research Strategy
- Specific Aims
- Preliminary Data (analytical or clinical)
- Biospecimen/Data Resource Plan (for UH3)
- Budget and Budget Justification
- Key Personnel Biographical Sketches
- Timeline and Milestones
- Letters of Support (institutional, clinical sites)
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 5 awards $103.0M
- 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 can apply for this grant?
Research institutions, universities, hospitals, federal agencies, faith-based organizations, and tribal governments can apply. Non-U.S. entities are ineligible, but foreign components of U.S. organizations are permitted.
What is the difference between UH2 and UH3 phases?
UH2 supports analytical validation of assays within 2 years. UH3 supports clinical validation of analytically validated assays using biospecimens from trials, lasting up to 3 years.
Can we validate assays for uses beyond cancer clinical trials?
Yes. You can validate existing assays for observational studies, population studies, and harmonize clinical laboratory tests across multiple labs.
What types of markers can we validate?
You can validate molecular, cellular, and imaging markers for detection, diagnosis, prognosis, treatment response, toxicity, and cancer prevention. Immune markers and pharmacodynamic markers are appropriate.
Do I need to have an assay already developed before applying?
Yes. Your assay should be developed, working on human samples, and have well-justified clinical importance. You're validating existing assays, not developing new ones.
💡 Tips for applicants
- Assemble a multi-disciplinary team early. Include oncologists, statisticians, clinical laboratory scientists, and scientific investigators for a competitive application.
- Clearly demonstrate that your assay is already functional on human samples and that clinical validation is justified by existing evidence.
- For UH2 applications, create a realistic 2-year timeline for analytical validation with specific milestones and quality metrics.
- For UH3 applications, plan access to well-annotated biospecimens from existing clinical trials or prospective studies before you apply.
- Consider emphasizing immune markers or combination assay development, as these align with current advances in cancer therapy integration.
⚠️ Common mistakes
Applications often lack adequate analytical validation data before proposing clinical studies, causing rejection. Proposals without committed multi-disciplinary teams or clear roles appear weak. Insufficient detail on biospecimen access or study population characteristics undermines UH3 applications.
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