Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.
If you have an analytically validated cancer biomarker assay ready to prove its clinical utility, this 3-year NIH grant can fund that validation work at scale.
Report stale or inaccurate summary
What this is
This NIH NCI program funds clinical validation of molecular, cellular, or imaging biomarker assays for cancer detection, diagnosis, prognosis, treatment response prediction, and toxicity monitoring. Applicants must already have assays with demonstrated analytical validity and propose to validate them in clinical settings using retrospective or prospective specimens. The funding is appropriate for multi-lab harmonization studies and validation work that would enable assays to be used as investigational tools in future clinical trials, but does not support early-stage technology development or conducting new clinical trials.
Who can apply
Small businesses, nonprofits (with or without 501(c)(3) status), for-profit organizations, universities, tribal organizations, and government entities are eligible. There is no stated geographic restriction. Applicants must have an assay already analytically validated and ready for clinical validation; early-stage technology development is not supported.
Eligible applicant types
- City or township governments
- Native American tribal governments (Federally recognized)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Small businesses
- For profit organizations other than small businesses
- Special district governments
- Public housing authorities/Indian housing authorities
- Private institutions of higher education
- County governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- State governments
- Public and State controlled institutions of higher education
- Independent school districts
- Native American tribal organizations (other than Federally recognized tribal governments)
Full description — from the agency
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.
Topics: cancer biomarker validation · assay validation · clinical specimens · molecular markers · diagnostic assays · nih funding
Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.