Data / Federal grants / PAR-26-091

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

National Institutes of Health (Department of Health and Human Services) expects to post this opportunity around February 16, 2026, with applications due around February 8, 2027.

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Key facts

Opportunity number

PAR-26-091

Status

Forecast

Posted

December 8, 2025

Closes

February 8, 2027

Cost sharing

Not required

Funding instrument

Cooperative Agreement

Category

Health

Assistance listing

93.394 Cancer Detection and Diagnosis Research

Contact

Cancer Diagnosis Program · [email protected] · Phone: 240-276-5748

Who can apply

• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Public and State controlled institutions of higher education
• City or township governments
• Special district governments
• Independent school districts
• Small businesses
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• State governments
• For profit organizations other than small businesses
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• County governments
• Private institutions of higher education
• Public housing authorities/Indian housing authorities
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized tribal governments)

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;

What the agency says

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.

The notice on Grants.gov

Other open grants from the Department of Health and Human Services

All grants open to Nonprofits (501(c)(3)) · All grants open to Public colleges and universities · All grants open to City or township governments · Everything closing in February 2027

Read from the Grants.gov API, last updated 2026-10-23. The agency's notice on Grants.gov is the official record; check it before you apply.