Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers with established assays seeking clinical validation support. Applicants can submit either a 5-year biphasic UH2/UH3 application (analytical then clinical validation) or a 3-year monophasic UH3 application (clinical validation only). The UH3 track requires analytical validation already completed in specimens similar to intended use.
Projects must optimize existing assays using human specimens for cancer detection, diagnosis, prognosis, monitoring, or treatment response prediction. Multidisciplinary teams including oncologists, statisticians, and laboratory scientists are expected. Applicants must propose well-justified markers and demonstrate feasibility of assay development in clinical laboratory settings.
Not the right fit? Find grants for your organization in 5 questions →
Key dates
- Dec 8, 2025 Applications open
- Feb 8, 2027 Application deadline in 206 days
- Dec 1, 2027 Award announced
- Dec 1, 2027 Project start
Program description
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits 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. The applicants have the option of submitting either a biphasic UH2/UH3 (Developmental Cooperative Agreement Phase I/Developmental Cooperative Agreement Phase II) application for 5 years or a monophasic standalone UH3 (Developmental Cooperative Agreement Phase II) application for 3 years to support clinical validation of established assays. The UH2 phase of this NOFO will support analytical validation of assays for the markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO will support clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. Investigators applying for UH2/UH3 must address both UH2 and UH3 phases, and propose milestones to be accomplished in the UH2 phase for transition to the UH3 phase. Applicants to the stand alone UH3 must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended use of the assay(s) and marker(s).
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 durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. Investigators applying in response to this NOFO must propose optimizing an existing assay(s) using human specimens in a clinical laboratory into assays that can be used in a clinical trial/study for the treatment, prevention or control of cancer.
This NOFO may be used to validate existing assays for use in other 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 multidisciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. Clinically validated assays are expected to provide new useful tools for cancer risk/survival assessment, precision cancer prevention and control, for guiding cancer therapy decisions, and for better management of cancer patients.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (federal application form)
- Research Strategy (project narrative)
- Biographical Sketches (all key personnel)
- Budget and Budget Narrative
- Facilities and Other Resources
- Support and Vertebrate Animals (if applicable)
- Letters of Collaboration (for multidisciplinary team members)
Program contact
- 👤 Cancer Diagnosis Program
- 📧 NCICDPNOFO@mail.nih.gov
- 📞 Phone: 240-276-5748
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
-
$37,552,767
-
$36,939,788
-
$35,037,695
-
$30,393,940
-
$30,179,102
-
$18,390,244
-
$18,143,614
Top States by Funding
- PA 10 awards $135.7M
- WA 7 awards $122.3M
- CA 12 awards $108.0M
- TX 8 awards $92.9M
- OH 5 awards $73.2M
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
Can I apply for a UH2/UH3 biphasic grant?
Yes, this allows 5 years total with 2 years for analytical validation (UH2) then up to 3 years for clinical validation (UH3). You must address both phases and propose clear milestones for transition.
Do I need analytical validation completed before applying for UH3?
Yes, standalone UH3 applicants must have assays already analytically validated in specimens similar to their intended clinical use.
What types of markers and assays are eligible?
Markers for cancer detection, diagnosis, prognosis, monitoring, treatment response, toxicity, and pharmacodynamic effects are supported. Immune markers combined with other assays are also appropriate.
How competitive is this funding opportunity?
NIH cancer research is highly competitive. Strong applications require rigorous study design, well-characterized biospecimens, experienced multidisciplinary teams, and clear clinical utility.
What is the typical funding range?
Award amounts are not specified in the NOFO. Contact the program officer for estimated budget ranges for your project scope.
💡 Tips for applicants
- Clarify your validation phase: decide whether biphasic (UH2/UH3) or monophasic (UH3 alone) best fits your assay's current stage. Ensure you meet the prerequisites for your chosen track.
- Build a strong multidisciplinary team including oncologists, statisticians, bioinformaticians, and laboratory directors with clinical validation experience.
- Use well-annotated biospecimens from existing retrospective or prospective studies to reduce delays and strengthen feasibility.
- Propose specific, measurable milestones for the UH2 phase before transitioning to UH3 clinical validation work.
- Demonstrate clinical utility and impact: explain how your validated assay will change cancer management, risk assessment, or treatment decisions.
⚠️ Common mistakes
Submitting UH2/UH3 without clear, achievable analytical validation milestones for the first 2 years. Applying for standalone UH3 without prior analytical validation in relevant specimens. Underestimating the time and resources needed for multidisciplinary collaboration and clinical trial coordination.
Similar grants
- OPEN Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) — National Institutes of Health
- OPEN Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Advanced Development and Validation of Emerging Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) — National Institutes of Health
- OPEN Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) — National Institutes of Health