OpenFederal grantOpen to for-profit businessesPAR-25-075

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

National Institutes of HealthCloses Oct 14, 2026(1 day left)Up to $250,000

Does this fit your business?

This is an NIH/NCI grant for organizations that already have an analytically validated cancer biomarker assay and need to validate it clinically using specimens from existing trials or studies. It is not for early-stage technology development or clinical trials. Small businesses and for-profits can apply, but if you have no established assay or no access to clinical specimens, do not bother.

Best for
Small biotech or diagnostics companies with an already analytically validated cancer biomarker assay, Cancer centers and universities with clinical trial specimens and lab collaborators, Nonprofits and clinical laboratory groups validating assays across labs, State, local, or tribal government entities supporting cancer research
Not for
Startups still building or inventing an assay — early-stage technology development is explicitly out of scope, Anyone planning to run a clinical trial — clinical trials are not allowed under this mechanism, Businesses with no existing analytically validated cancer biomarker assay or access to clinical specimens
Estimated fit by industry, best first
IndustryEstimated fit
Healthcare & BiotechMatches your industry (clinical)
69
Good Match
Technology & SoftwareMatches your industry (technology, tech)
61
Good Match
Environment & ConservationLimit: Closes in 26 days
54
Possible Match
Energy & Clean TechLimit: Closes in 26 days
53
Possible Match
Social Services & NonprofitLimit: Closes in 26 days
53
Possible Match
Arts & CultureLimit: Closes in 26 days
52
Possible Match
Show all 15 industries
Estimated fit by industry, best first
IndustryEstimated fit
Education & TrainingLimit: Closes in 26 days
51
Possible Match
Food & BeverageLimit: Closes in 26 days
49
Possible Match
Housing & Real EstateLimit: Closes in 26 days
49
Possible Match
ManufacturingLimit: Closes in 26 days
48
Possible Match
Agriculture & FarmingLimit: Closes in 26 days
47
Possible Match
Finance & BankingLimit: Closes in 26 days
45
Possible Match
Retail & E-CommerceLimit: Closes in 26 days
44
Possible Match
Transportation & LogisticsLimit: Closes in 26 days
43
Possible Match
Construction & InfrastructureLimit: Closes in 26 days
42
Possible Match

These are our matcher’s estimates for a typical business in each industry. A real match depends on your size, your state and what you need the money for — check your own fit.

What this funds

Money can be used for
Research, Clinical validation, Assay development, Biomarker validation
Who can apply
Small businesses, For-profit companies, Nonprofits, State and local governments, Tribal governments and organizations, Colleges and universities, Other applicants (see eligibility)
Award range
Up to $250,000

Questions about this grant

When is the application deadline?
October 14, 2026.
How much funding can an applicant receive?
The largest award listed is $250,000. No other award amounts are published.
Who can apply for this grant?
Small businesses, for-profit organizations, nonprofits, universities, state, local, county, and tribal governments, independent school districts, public housing authorities, and certain federal agencies can apply. Foreign organizations and non-U.S. components of U.S. organizations are not eligible.
Can a sole proprietor or single-member LLC apply?
The facts do not say. Small businesses and for-profit organizations are eligible applicant types, but the notice does not address sole proprietors or single-member LLCs specifically.
Can a nonprofit apply?
Yes. Nonprofits with or without 501(c)(3) status (other than institutions of higher education) are listed as eligible, and faith-based or community-based organizations are also named.

Summary

NIH/NCI UH3 cooperative agreement to clinically validate established molecular, cellular, or imaging biomarker assays for cancer detection, diagnosis, prognosis, monitoring, or treatment response using specimens from clinical trials or studies. Eligible applicants include small businesses, for-profit organizations, nonprofits, universities, state/local/tribal governments, and federal agencies; U.S

About this grant

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.

Who can apply

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.

Topics and uses of funds

Topics

  • Health
  • Science
  • Cancer
  • Biomarkers
  • Clinical research

Program contact

National Institutes of Healthgrantsinfo@nih.gov301-402-2541

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