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

National Institutes of Health · Opportunity PAR-25-074

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities
• Native American tribal organizations (other)
• Nonprofits with 501(c)(3), other than higher education
• Nonprofits without 501(c)(3)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

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.

About this opportunity

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.

Award history — this exact opportunity

NIH RePORTER lists 2 funded awards under PAR-25-074 across 2 organizations.

Recent awardees include: RESEARCH INST OF FOX CHASE CAN CTR, H. LEE MOFFITT CANCER CTR & RES INST.

Source: NIH RePORTER, matched on the exact opportunity number. NIH publishes success rates by institute and activity code — source.

Portfolio context — this listing covers more than this opportunity

This opportunity is funded under Assistance Listing 93.394 (“Cancer Detection and Diagnosis Research”), a broad federal program that made about 242 new awards per year over the last five fiscal years (median award $1.1M). Those figures describe that whole portfolio — not this specific solicitation, so we don't show them as if they were this opportunity's track record.

Applicant counts per solicitation are not published by any federal agency — no one can honestly sell you that number. NIH publishes success rates by institute and activity code — source.

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