Grants / Department of Health and Human Services / National Institutes of Health

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

Forecast Expected deadline February 8, 2027 Opportunity PAR-26-091

• Award ceilingnot stated
• Award floornot stated
• Expected awardsnot stated
• Total fundingnot stated
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

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Who can apply

This opportunity is open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

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

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;

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• No cost sharing or match is required.

What the grant funds

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.

Category: Health.

How to apply

1. Read the full notice and attachments on Grants.gov. The notice is the official source for deadlines and requirements.
2. Make sure your organization has an active SAM.gov registration and Unique Entity ID; registration can take several weeks.
3. Register on Grants.gov and submit through Workspace before the deadline and time given in the notice. Our application guide walks through each step.

Questions go to Cancer Diagnosis Program, NCICDPNOFO@mail.nih.gov, Phone: 240-276-5748.

Open the official notice