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Federal Open GRANTS-GOV-356718

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

National Institutes of Health (NIH) · Competitive grant · Science & Technology

At a glance

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) is a federal competitive grant from National Institutes of Health for the science & technology sector. Eligible applicants: Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Others (see text field entitled "Additional Information on Eligibility" fo. The application deadline is October 14, 2026. Apply via the official listing at www.grants.gov.

Amount
See listing
Deadline
Oct 14, 2026
Type
Competitive
Status
Open

About this program

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

Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; County governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); State governments; Public housing authorities/Indian housing authorities; Small businesses; City or township governments; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments); Private institutions of higher education; Special district governments; Public and State controlled institutions of higher education; For profit organizations other than small businesses; Native American tribal governments (Federally recognized). Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

How to apply

Apply through Grants.gov using funding opportunity number PAR-25-074. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source