Opportunity Information: Apply for PAR 25 075
This funding opportunity (PAR-25-075) is a National Cancer Institute (NCI) Notice of Funding Opportunity designed to push cancer biomarkers and their associated assays from the stage of being analytically sound in the lab to being clinically validated and ready to plug into real-world clinical studies. The central goal is to speed up the adoption of high-quality molecular, cellular, and imaging markers that can be used for cancer detection and diagnosis, prognosis, disease monitoring, and predicting whether a patient is likely to respond to treatment or develop resistance. It also explicitly includes biomarkers used in cancer prevention and cancer control, plus pharmacodynamic markers (signals that a drug is hitting its intended target or producing a biological effect) and markers that help measure or predict toxicity.
A key point is that applicants are not being asked to invent brand-new biomarker technologies from scratch. To be competitive and responsive, a project needs to start with an assay (or assays) that is already analytically validated, meaning the applicant has evidence the test performs reliably in the kinds of specimens that match the intended clinical use. In other words, the program is aimed at the next step: clinical validation. That means demonstrating that an established assay, run under appropriate conditions, yields results that are clinically meaningful when applied to samples and data tied to clinical outcomes. This is also why the NOFO emphasizes that it is not intended to support early-stage technology development, and it does not support the conduct of clinical trials.
The award mechanism is the UH3 cooperative agreement, which signals substantial NIH involvement and an expectation of active coordination between the funded team and NCI program staff compared with a traditional grant. Under this mechanism, the NOFO supports up to three years of clinical validation work. The clinical validation can be done using specimens and associated data from retrospective studies (for example, archived samples from completed trials or cohorts) or prospective clinical trials or studies, as long as the work is about validating the assay using specimens from those efforts rather than running a new clinical trial under this award. The NOFO also notes that validated assays coming out of these projects are intended to be ready for integration into future clinical trials or clinical studies as investigational assays.
The opportunity reflects current treatment realities in oncology, particularly the increasing use of combination regimens that mix chemotherapy and/or radiation with immunotherapies. Because these approaches often require a more complete picture of tumor biology and immune response, the NOFO explicitly supports developing and validating assays that can measure multiple markers at once, including immune markers. That can include multiplex strategies where a single platform or workflow captures several biologically relevant signals in parallel, as long as the assays are already established enough to be in the validation phase rather than exploratory invention.
Another major theme is harmonization and reproducibility across laboratories. The NOFO encourages projects that look at how well clinical laboratory tests perform when used in multiple clinical labs, which gets at a frequent barrier to biomarker adoption: an assay that works well in one setting but shows variability when transferred to another. Work that evaluates inter-laboratory performance, reproducibility, and comparability of results is considered appropriate, supporting the broader aim of making assays robust enough for broad clinical study use.
Because clinical validation is inherently cross-cutting, NCI expects multidisciplinary teams. The NOFO calls out the need for meaningful collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. That emphasis signals that proposals should have credible clinical context (what decision or outcome the biomarker is meant to inform), strong statistical planning (how performance and clinical validity will be evaluated, including reproducibility and bias considerations), and operational laboratory expertise (standardization, quality control, and realistic workflows).
From an administrative standpoint, this is a discretionary funding opportunity offered by the National Institutes of Health (NIH), with NCI as the sponsoring institute. The funding instrument is a cooperative agreement, and it is categorized under Education and Health with CFDA number 93.394. The listed award ceiling is $250,000. The original closing date shown is 2026-10-14.
Eligibility is broad across U.S.-based organizational types, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education if applicable); for-profit organizations (other than small businesses); and small businesses. The NOFO also highlights several institution types and community-focused organizations as eligible (such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations). At the same time, it clearly states that non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible. However, foreign components, as NIH defines them in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant organization may include certain foreign collaborations or elements when justified and compliant with NIH policy.
Overall, the program is best understood as a bridge between lab-level assay readiness and practical adoption in clinical research settings. It prioritizes assays that are already analytically credible, then funds the work needed to prove clinical validity, demonstrate reproducibility (including across labs when relevant), and position the assay so it can be confidently used as an investigational tool in future cancer clinical trials, observational studies, and population studies.Apply for PAR 25 075
- 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 (UH3 Clinical Trials 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.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- 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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FAQs: NCI PAR-25-075 Cancer Biomarker Clinical Validation (UH3)
What is PAR-25-075 trying to fund?
PAR-25-075 is a National Cancer Institute (NCI) Notice of Funding Opportunity that supports moving cancer biomarkers and their associated assays from being analytically validated in the laboratory to being clinically validated and ready to use as investigational assays in real-world clinical studies.
What is the main goal of this opportunity?
The central goal is to speed the adoption of high-quality molecular, cellular, and imaging biomarkers for cancer detection and diagnosis, prognosis, disease monitoring, and predicting treatment response or resistance. The scope also includes biomarkers for cancer prevention and cancer control, pharmacodynamic biomarkers, and biomarkers that help measure or predict toxicity.
Does this program support inventing brand-new biomarker technologies?
No. The opportunity is not intended to fund early-stage technology development or invention of new biomarker technologies from scratch. Projects are expected to start with assays that are already analytically validated.
What does "analytically validated assay" mean in the context of this NOFO?
It means the applicant already has evidence that the assay performs reliably in specimen types that match the intended clinical use. In other words, the test has demonstrated dependable analytical performance under relevant sample conditions, and the project is now focused on the next step: clinical validation.
What does "clinical validation" mean for this funding opportunity?
Clinical validation, as emphasized here, involves demonstrating that an established assay produces results that are clinically meaningful when applied to specimens and data linked to clinical outcomes.
Does PAR-25-075 fund clinical trials?
No. The NOFO explicitly states it does not support the conduct of clinical trials under this award. The focus is validating assays using specimens and associated data tied to clinical outcomes, rather than running a new clinical trial as part of the grant.
Can clinical validation be done with retrospective specimens and data?
Yes. The NOFO allows clinical validation using specimens and associated data from retrospective studies, such as archived samples from completed trials or existing cohorts.
Can clinical validation be done using specimens from prospective trials or studies?
Yes. The NOFO allows clinical validation using specimens and associated data from prospective clinical trials or studies, as long as the award supports the validation work (using specimens from those efforts) and does not support conducting the clinical trial itself.
What is the award mechanism for PAR-25-075?
The funding mechanism is the UH3 cooperative agreement, which indicates substantial NIH involvement and active coordination between the funded team and NCI program staff compared to a traditional grant.
How long can the project period be under this opportunity?
The NOFO supports up to three years of clinical validation work under the UH3 mechanism.
What is meant by "cooperative agreement" in this context?
A cooperative agreement (UH3) signals that NIH/NCI expects to be substantially involved in the project, with more active coordination and engagement by NCI program staff than would typically occur under a standard research grant.
What kinds of biomarkers are included?
The NOFO includes molecular, cellular, and imaging biomarkers used for detection/diagnosis, prognosis, monitoring, and prediction of response or resistance. It also explicitly includes biomarkers used in cancer prevention and cancer control, pharmacodynamic biomarkers, and biomarkers related to toxicity measurement or prediction.
Does the NOFO support multiplex or multi-marker assays?
Yes. The NOFO explicitly supports assays that can measure multiple markers at once, including immune markers, reflecting modern oncology where combination treatments often require a broader view of tumor biology and immune response.
Are immune markers within scope?
Yes. Immune markers are explicitly called out as part of the multi-marker measurement capabilities supported by the NOFO.
What stage must multiplex assays be in to be responsive?
They must be established enough to be in the clinical validation phase, not exploratory invention. The program expects assays to already be analytically validated before applying.
Is harmonization and reproducibility across labs part of the intended scope?
Yes. A major theme is harmonization and reproducibility across laboratories. Projects evaluating inter-laboratory performance, reproducibility, and comparability of results are encouraged.
Why is inter-laboratory performance important to this program?
The NOFO highlights that variability between laboratories is a common barrier to biomarker adoption. Demonstrating consistent performance across clinical labs supports broader use of an assay in clinical studies.
What kinds of teams does NCI expect for these projects?
NCI expects multidisciplinary teams with meaningful collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists, reflecting the cross-cutting nature of clinical validation.
What does NCI seem to expect in terms of clinical context and analysis planning?
The NOFO’s emphasis suggests proposals should present a credible clinical context (what decision or outcome the biomarker is meant to inform), strong statistical planning for evaluating performance and clinical validity (including reproducibility and bias considerations), and solid clinical laboratory expertise for standardization and quality control.
What is the intended outcome of a successful project?
The NOFO indicates that assays validated through these projects should be ready for integration into future clinical trials or clinical studies as investigational assays.
Which agency and institute sponsor this opportunity?
This is a discretionary funding opportunity offered by the National Institutes of Health (NIH), with the National Cancer Institute (NCI) as the sponsoring institute.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.394.
What category is this opportunity listed under?
It is categorized under Education and Health.
What is the award ceiling?
The listed award ceiling is $250,000.
What is the closing date shown for the opportunity?
The original closing date shown is 2026-10-14.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizational types, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education if applicable); for-profit organizations (other than small businesses); and small businesses.
Are community-focused or minority-serving institutions eligible?
Yes. The NOFO highlights eligibility for several institution types and community-focused organizations, including HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
Are non-U.S. (non-domestic) entities eligible to apply directly?
No. The NOFO states that non-domestic (non-U.S.) entities are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. The NOFO states that non-domestic components of U.S. organizations are not eligible.
Are foreign components allowed at all?
Yes. The NOFO indicates that foreign components (as defined by NIH in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain foreign collaborations or elements when justified and compliant with NIH policy.
What is the best overall way to think about the purpose of this program?
It is positioned as a bridge between lab-level assay readiness and practical adoption in clinical research settings: taking analytically credible assays, validating them clinically, demonstrating reproducibility (including across laboratories when relevant), and preparing them to be confidently used as investigational tools in future cancer clinical trials and clinical studies.
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|---|
| Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R34 Clinical Trial Optional) Apply for RFA DA 25 070 Funding Number: RFA DA 25 070 Agency: National Institutes of Health Category: Education, Health Funding Amount: $450,000 |
| Ending the Epidemic: New Models of Integrated HIV/AIDS, Addiction, and Primary Care Services (R01 Clinical Trial required) Apply for RFA DA 25 072 Funding Number: RFA DA 25 072 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) Apply for PAR 25 074 Funding Number: PAR 25 074 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required) Apply for PAR 26 001 Funding Number: PAR 26 001 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Co-infection and Cancer (R01 Clinical Trial Not Allowed) Apply for PAR 25 082 Funding Number: PAR 25 082 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Small Grants Program for Cancer Research (NCI Omnibus) (R03 Clinical Trial Optional) Apply for PAR 25 078 Funding Number: PAR 25 078 Agency: National Institutes of Health Category: Education, Health Funding Amount: $50,000 |
| The Metastasis Research Network (MetNet): MetNet Research Projects (U01 Clinical Trial Not Allowed) Apply for PAR 25 130 Funding Number: PAR 25 130 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Targeting Inflammasomes in HIV and Substance Use (R21 Clinical Trial Not Allowed) Apply for RFA DA 25 068 Funding Number: RFA DA 25 068 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| 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 |
| Targeting Inflammasomes in HIV and Substance Use (R01 Clinical Trial Not Allowed) Apply for RFA DA 25 069 Funding Number: RFA DA 25 069 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Biomedical Research Environment and Sponsored Programs Administration Development (BRE-SPAD) Program (UC2- Clinical Trial Not Allowed) Apply for PAR 24 268 Funding Number: PAR 24 268 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Mechanistic links between diet, lipid metabolism, and tumor growth and progression (UH2 Clinical Trial Not Allowed) Apply for PAR 25 118 Funding Number: PAR 25 118 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Enhancing Mechanistic Research on Precision Probiotic Therapies (R61/R33 Clinical Trial Optional) Apply for PAR 25 211 Funding Number: PAR 25 211 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Enhancing Mechanistic Research on Precision Probiotic Therapies (R33 Clinical Trial Optional) Apply for PAR 25 210 Funding Number: PAR 25 210 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Mechanistic links between diet, lipid metabolism, and tumor growth and progression (U01 Clinical Trial Not Allowed) Apply for PAR 25 119 Funding Number: PAR 25 119 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Clinical and Translational Exploratory/Developmental Studies (R21 Clinical Trial Optional) Apply for PAR 25 139 Funding Number: PAR 25 139 Agency: National Institutes of Health Category: Education, Health Funding Amount: $275,000 |
| Addressing Challenges in Detecting New Drugs: Instrumentation for Alternative Analytical Methods (R43/R44 - Clinical Trials Optional) Apply for RFA DA 26 018 Funding Number: RFA DA 26 018 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Addressing Challenges in Detecting New Drugs: Instrumentation for Alternative Analytical Methods (R41/R42 - Clinical Trials Optional) Apply for RFA DA 26 019 Funding Number: RFA DA 26 019 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional) Apply for PAR 25 104 Funding Number: PAR 25 104 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional) Apply for PAR 25 103 Funding Number: PAR 25 103 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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