Opportunity Information: Apply for PAR 25 074
The National Cancer Institute (NCI) is offering a cooperative agreement funding opportunity (PAR-25-074) to move promising cancer biomarkers and the assays that measure them closer to real clinical use. The focus is on validating molecular, cellular, and imaging markers that can help with cancer detection and diagnosis, estimating prognosis, monitoring disease, and predicting whether a patient is likely to respond to a treatment or develop resistance. The program also explicitly welcomes pharmacodynamic markers (signals that a drug is hitting its intended target or having its intended biological effect) and markers of toxicity, which can be important for making treatments safer and for guiding dose or regimen decisions.
A central requirement is that applicants come in with assays that already work on human samples and have a strong rationale for why the marker matters clinically. This is not meant to be early discovery work; it is meant to tighten up performance, demonstrate reliability, and establish evidence that the assay can be trusted in the kinds of clinical studies NCI supports. Because cancer therapy is increasingly combining chemotherapy and/or radiation with immunotherapies, the NOFO encourages development and validation of assays that can measure multiple markers at once, including immune-related markers, so that complex biological responses can be captured more realistically.
The award uses a two-phase UH2/UH3 structure with clear milestones. The UH2 phase supports analytical validation and must be completed within 2 years. In practical terms, analytical validation is about proving the assay itself is technically sound and fit-for-purpose: how accurate it is, how precise and reproducible it is, what its limits of detection and quantification are, how robust it is to variables like sample handling, storage, and operator differences, and whether results are consistent across runs, instruments, and potentially sites. Only after these analytical benchmarks are met can a project transition into the UH3 phase. The UH3 phase supports clinical validation for up to 3 years, using well-annotated biospecimens and associated clinical data drawn from retrospective or prospective clinical trials or studies. The goal in UH3 is to show that the analytically validated assay meaningfully relates to clinically relevant endpoints (for example, confirming that a biomarker-based assay result predicts response, recurrence risk, progression, or toxicity in the intended context of use).
This NOFO is flexible in that it can be used to validate an existing assay for deployment in additional NCI-supported cancer trials, observational studies, or population studies, not only for brand-new assay concepts. It also supports harmonization work, which matters when the same lab test needs to perform consistently across different clinical laboratories. Projects that evaluate inter-lab reproducibility, standardization of protocols, and cross-site performance are considered aligned with the opportunity, reflecting a practical emphasis on real-world implementability rather than single-lab success.
Given the complexity of assay validation and the need for credible clinical evidence, NCI expects applicants to build multi-disciplinary teams. Competitive projects will typically integrate expertise from basic and translational scientists, oncologists who understand clinical contexts and endpoints, statisticians who can design robust validation studies and analyses, and clinical laboratory scientists who can address assay performance, quality systems, and reproducibility considerations. Importantly, the NOFO is labeled "Clinical Trial Not Allowed," meaning the supported work should focus on validation using specimens and data from existing trials or studies (retrospective or prospective), rather than initiating a new interventional clinical trial under this award.
Eligibility is broad and includes many U.S.-based organizational types, such as state and local governments, public and private institutions of higher education, federally recognized tribal governments, tribal organizations, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), independent school districts, public housing authorities/Indian housing authorities, and other entities. The NOFO also calls out a range of mission-serving institutions and community-facing organizations as eligible, including HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions. Non-U.S. (foreign) organizations are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, foreign components (as NIH defines them in its policy framework) are allowed, which can enable certain kinds of international collaboration or specialized contributions without making the project foreign-led.
Administratively, this is an NIH/NCI cooperative agreement, which typically implies a more substantial programmatic partnership with NCI staff than a standard grant mechanism. The opportunity lists an original closing date of 2026-10-14 and is associated with CFDA 93.394. The award ceiling and expected number of awards are not specified in the provided listing, so applicants would need to consult the full NOFO and related NIH guidance for budget expectations, milestone requirements, and review criteria details.Apply for PAR 25 074
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
- This funding opportunity was created on 2024-10-15.
- Applicants must submit their applications by 2026-10-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: 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.
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Frequently Asked Questions (FAQs) - NCI Cooperative Agreement PAR-25-074 (UH2/UH3)
1. What is the main goal of this NCI funding opportunity (PAR-25-074)?
The goal is to move promising cancer biomarkers and the assays that measure them closer to real clinical use by supporting rigorous validation. The opportunity focuses on improving assay performance, demonstrating reliability, and building evidence that an assay can be trusted in the kinds of clinical studies supported by NCI.
2. What kinds of biomarkers and assays are in scope?
The opportunity supports validation of molecular, cellular, and imaging markers and their assays. These markers may be used for cancer detection and diagnosis, estimating prognosis, monitoring disease, and predicting treatment response or resistance.
3. Are pharmacodynamic biomarkers and toxicity markers allowed?
Yes. The program explicitly welcomes pharmacodynamic markers (signals that a drug is hitting its intended target or achieving its intended biological effect) and markers of toxicity, which may help guide safer treatments and inform dose or regimen decisions.
4. Is this opportunity meant for early-stage biomarker discovery?
No. This opportunity is not intended for early discovery work. Applicants are expected to propose assays that already work on human samples and to provide a strong rationale for why the biomarker is clinically meaningful.
5. What does NCI mean by coming in with assays that already work on human samples?
Based on the description, applicants should already have an assay that functions on human specimens prior to award, and the project should focus on tightening performance, demonstrating reliability, and supporting evidence for use in NCI-relevant clinical research contexts.
6. Why does the NOFO emphasize multi-marker assays and immune-related markers?
Because cancer therapy increasingly combines chemotherapy and/or radiation with immunotherapies, the NOFO encourages assays that can measure multiple markers at once, including immune-related markers, to capture complex biological responses more realistically.
7. What is the award structure for this opportunity?
This funding opportunity uses a two-phase UH2/UH3 structure with clear milestones. The UH2 phase supports analytical validation (up to 2 years). After meeting analytical milestones, projects may transition into the UH3 phase, which supports clinical validation (up to 3 years).
8. How long is the UH2 phase, and what is it used for?
The UH2 phase must be completed within 2 years and supports analytical validation, focused on demonstrating that the assay is technically sound and fit-for-purpose.
9. What types of work are included in analytical validation (UH2)?
Analytical validation activities described include evaluating accuracy, precision and reproducibility, limits of detection and quantification, robustness to variables such as sample handling and storage, operator differences, and consistency across runs, instruments, and potentially across sites.
10. What triggers the transition from UH2 to UH3?
Transition is dependent on meeting the analytical benchmarks/milestones established for UH2. Only after these analytical validation milestones are met can the project move into UH3 clinical validation.
11. How long is the UH3 phase, and what is it used for?
The UH3 phase supports clinical validation for up to 3 years. The purpose is to show that the analytically validated assay meaningfully relates to clinically relevant endpoints in the intended context of use.
12. What kinds of data and samples are expected for clinical validation (UH3)?
Clinical validation is expected to use well-annotated biospecimens and associated clinical data drawn from retrospective or prospective clinical trials or studies.
13. What kinds of clinically relevant endpoints might be supported in UH3?
Examples given include demonstrating that an assay result predicts response, recurrence risk, progression, or toxicity, in the intended context of use.
14. Can this NOFO be used to validate an existing assay for use in additional NCI-supported studies?
Yes. The NOFO is described as flexible and can be used to validate an existing assay for deployment in additional NCI-supported cancer trials, observational studies, or population studies, not only for brand-new assay concepts.
15. Does the opportunity support harmonization and cross-laboratory standardization?
Yes. Harmonization work is explicitly supported, including projects that evaluate inter-lab reproducibility, standardization of protocols, and cross-site performance, emphasizing real-world implementability rather than single-lab success.
16. What kinds of teams does NCI expect applicants to build?
NCI expects multi-disciplinary teams, typically integrating basic and translational scientists, oncologists who understand clinical contexts and endpoints, statisticians to design robust validation studies and analyses, and clinical laboratory scientists focused on assay performance, quality systems, and reproducibility.
17. Are clinical trials allowed under this funding opportunity?
No. The NOFO is labeled "Clinical Trial Not Allowed." The supported work should focus on validation using specimens and data from existing trials or studies (retrospective or prospective), rather than initiating a new interventional clinical trial under this award.
18. Who is eligible to apply?
Eligibility is broad for U.S.-based organizations and includes state and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (including small businesses); independent school districts; public housing authorities/Indian housing authorities; and other eligible entities listed in the opportunity description.
19. Are specific mission-serving and community-facing organizations included as eligible?
Yes. The listing calls out eligibility for organizations such as HBCUs, Hispanic-serving institutions, AANAPISISs, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, regional organizations, and U.S. territories or possessions.
20. Are non-U.S. (foreign) organizations eligible to apply?
No. Non-U.S. (foreign) organizations are not eligible to apply, and non-domestic components of U.S. organizations are not eligible.
21. Are any international components allowed at all?
Yes. While foreign organizations cannot apply as the applicant organization, foreign components (as NIH defines them in its policy framework) are allowed, which can support certain types of international collaboration or specialized contributions without making the project foreign-led.
22. What does it mean that this is an NIH/NCI cooperative agreement?
It means the award is a cooperative agreement mechanism, which typically implies more substantial programmatic partnership with NCI staff than a standard grant.
23. What is the closing date shown for this opportunity?
The opportunity lists an original closing date of 2026-10-14.
24. What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.394.
25. Is the award ceiling or expected number of awards provided?
No. The provided listing does not specify an award ceiling or the expected number of awards. Applicants would need to consult the full NOFO and related NIH guidance for budget expectations, milestone requirements, and review criteria details.
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| Computational Approaches to Curation at Scale for Biomedical Research Assets (R01 Clinical Trial Not Allowed) Apply for PAR 25 131 Funding Number: PAR 25 131 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
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