Opportunity Information: Apply for PAR 23 314
The National Cancer Institute (NCI) funding opportunity "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)" (PAR-23-314) is designed to move promising cancer biomarkers and their associated assays closer to real-world clinical research use by supporting rigorous clinical validation. The central goal is to speed adoption of well-characterized molecular, cellular, and imaging markers that can improve cancer detection and diagnosis, guide prognosis, track disease over time, and help predict whether a patient will respond to a therapy or develop resistance. The opportunity also explicitly includes biomarkers used in cancer prevention and control, along with pharmacodynamic markers (to show whether a drug is hitting its target or having the intended biologic effect) and markers of toxicity (to help understand or anticipate harmful treatment effects).
A key requirement is that applicants must already have an assay (or assays) with established analytical validation, meaning the test's technical performance has been demonstrated in specimens similar to those expected for the intended clinical use. In other words, this program is not meant for early proof-of-concept technology development or preliminary assay prototyping. Instead, it focuses on the next step: demonstrating that an assay that already works reliably in the lab can produce clinically meaningful results when applied to appropriate patient or participant specimens. This emphasis reflects a common bottleneck in biomarker science, where many markers show promise but fail to transition into broader clinical research because the evidence base is not strong enough, methods are not standardized, or results cannot be reproduced across settings.
The award uses the UH3 cooperative agreement mechanism, which generally means there is substantial scientific involvement from NIH program staff compared with a typical grant, often to help steer milestones, ensure harmonization, and maximize the value of the validation effort. The UH3 support is intended to last up to three years and fund clinical validation using specimens tied to retrospective or prospective clinical trials or studies. Importantly, while samples may come from clinical trials or studies, the NOFO does not support conducting a clinical trial itself, and the announcement is explicit that clinical trials are not allowed under this mechanism. The practical intent is to use existing or otherwise available specimen resources and associated clinical data to validate assays to the point where they can credibly be integrated into future clinical trials or clinical studies as investigational assays.
The scope is broad in terms of assay types and biomarker categories, including multi-marker approaches. The NOFO highlights the growing reality of combined modality cancer treatment, such as chemotherapy and/or radiation used alongside immunotherapies, and it encourages assays capable of measuring multiple markers at once, including immune markers. This matters because many clinically relevant questions now depend on integrated signals from tumor biology, the immune microenvironment, and treatment exposures, and single-analyte tests may be insufficient for modern study designs. Alongside validation, the NOFO also welcomes projects aimed at harmonizing clinical laboratory tests, including careful evaluation of assay performance and reproducibility across multiple clinical laboratories, which is often essential if an assay is to be trusted and used across multi-site networks and diverse patient populations.
Projects are expected to be strongly team-based and multidisciplinary. The NOFO calls out the need for interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. That combination reflects what is typically required for credible clinical validation: appropriate clinical context and endpoints, robust study design and statistical planning, rigorous specimen handling and laboratory quality systems, and clear plans to demonstrate assay reliability, reproducibility, and fitness-for-purpose in the intended setting.
In terms of eligibility, the opportunity is broadly accessible across many organization types, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities as permitted. The NOFO also notes specific categories of eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply; however, foreign components are allowed as defined in the NIH Grants Policy Statement, which can enable certain international collaborations when justified and structured appropriately.
From the provided source details, this is an NIH discretionary funding opportunity administered under the cooperative agreement instrument type, aligned with the health and education activity category, and associated with CFDA number 93.394. The original closing date listed is 2026-10-14. The source data also lists an award ceiling of 250,000, which should be interpreted carefully in context of NIH budgeting conventions and the specific NOFO text and application instructions, since NIH awards may specify direct cost limits, annual caps, or other budget constraints that depend on project scope and mechanism details.
Overall, this NOFO is best viewed as a translational bridge for cancer biomarkers: it is aimed at taking analytically validated assays and generating the clinical validation evidence and cross-lab confidence needed for them to be used reliably in future clinical trials, observational studies, and population research. It prioritizes assays that are ready for that step now, emphasizes reproducibility and harmonization, and supports work that can credibly change how cancer studies measure biology, treatment response, and risk.Apply for PAR 23 314
- 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 2023-10-31.
- 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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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)" and is identified as PAR-23-314.
Which agency is offering this grant?
This funding opportunity is offered by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH).
What is the main goal of PAR-23-314?
The main goal is to move promising cancer biomarkers and their associated assays closer to real-world clinical research use by supporting rigorous clinical validation. The program aims to speed adoption of well-characterized molecular, cellular, and imaging markers that can improve cancer detection and diagnosis, inform prognosis, track disease over time, and help predict treatment response or resistance.
What kinds of biomarkers are included in the scope?
The scope includes molecular, cellular, and imaging biomarkers, as well as biomarkers used in cancer prevention and control. It also explicitly includes pharmacodynamic markers (used to show whether a drug is engaging its target or producing the intended biologic effect) and toxicity markers (used to understand or anticipate harmful treatment effects). Multi-marker approaches are within scope.
What types of assays are supported?
The NOFO is broad in terms of assay types and biomarker categories, including multi-marker assays and approaches that measure multiple signals at once. It also encourages assays that can incorporate immune markers, reflecting the need to evaluate tumor biology, immune context, and treatment exposures together in modern cancer research.
Is this program for early-stage biomarker discovery or assay prototyping?
No. This program is not intended for early proof-of-concept technology development or preliminary assay prototyping. It focuses on clinical validation of assays that already have established analytical validation.
What does "analytical validation" mean in this context?
Analytical validation means the assay's technical performance has already been demonstrated in specimens similar to those expected for the intended clinical use. In practical terms, applicants are expected to start with an assay that already works reliably in the lab on appropriate specimen types.
What does the NOFO mean by "clinical validation"?
In this opportunity, clinical validation refers to demonstrating that an analytically validated assay can produce clinically meaningful results when applied to appropriate patient or participant specimens, using associated clinical data and study context to support credible conclusions.
Why is NCI emphasizing clinical validation and reproducibility?
The NOFO highlights a common bottleneck in biomarker science: many markers appear promising but do not transition into broader clinical research because evidence is insufficient, methods are not standardized, or results cannot be reproduced across settings. This program is meant to strengthen the evidence base and standardization needed for broader use.
What is the funding mechanism for this opportunity?
The award uses the UH3 cooperative agreement mechanism.
What does a "cooperative agreement" imply for the project?
A cooperative agreement generally means NIH program staff have substantial scientific involvement compared with a typical grant. This often includes helping steer milestones, encouraging harmonization, and maximizing the value of the validation effort.
How long can UH3 support last under this NOFO?
UH3 support is intended to last up to three years.
Are clinical trials allowed under this funding opportunity?
No. The announcement is explicit that clinical trials are not allowed under this mechanism.
If clinical trials are not allowed, can projects use samples from clinical trials?
Yes. The NOFO supports clinical validation using specimens tied to retrospective or prospective clinical trials or studies. The key distinction is that the award does not support conducting a clinical trial itself; it supports validation work using existing or otherwise available specimen resources and associated clinical data.
What types of studies or specimen resources can be used for validation?
The NOFO indicates that validation can be performed using specimens and clinical data from retrospective or prospective clinical trials or studies, with the practical intent of leveraging existing or otherwise available resources rather than initiating a new clinical trial.
What is the intended outcome of funded projects?
The intended outcome is to validate assays to the point where they can credibly be integrated into future clinical trials or clinical studies as investigational assays, supported by strong clinical validation evidence and, where relevant, cross-lab confidence in reproducibility.
Does the NOFO support harmonization of clinical laboratory tests across sites?
Yes. In addition to validation, the NOFO welcomes projects aimed at harmonizing clinical laboratory tests, including evaluation of assay performance and reproducibility across multiple clinical laboratories.
Why does cross-laboratory evaluation matter for this program?
Reproducibility across multiple clinical laboratories is often essential for an assay to be trusted and used across multi-site networks and diverse patient populations. The NOFO emphasizes this because multi-site adoption depends on consistent performance across settings.
Does the NOFO encourage multi-marker and immune-marker measurement?
Yes. The NOFO notes the growing reality of combined modality cancer treatment (for example, chemotherapy and/or radiation alongside immunotherapies) and encourages assays that can measure multiple markers at once, including immune markers.
What kinds of expertise are expected on project teams?
Projects are expected to be strongly team-based and multidisciplinary. The NOFO calls for interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists.
Why is a multidisciplinary team emphasized?
Credible clinical validation typically requires appropriate clinical context and endpoints, robust study design and statistical planning, rigorous specimen handling and laboratory quality systems, and clear plans to demonstrate assay reliability, reproducibility, and fitness-for-purpose.
Who is eligible to apply?
Eligibility is broad and includes many organization types, such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities as permitted.
Are specific institution categories explicitly noted as eligible?
Yes. The NOFO notes categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, and U.S. territories or possessions.
Are foreign (non-U.S.) institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are any international collaborations allowed?
Yes, foreign components are allowed as defined in the NIH Grants Policy Statement, which can enable certain international collaborations when justified and structured appropriately.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.394.
What activity category is this opportunity aligned with?
Based on the provided source details, it is aligned with the health and education activity category.
What is the application closing date shown in the provided details?
The original closing date listed in the provided details is 2026-10-14.
What is the listed award ceiling?
The source data lists an award ceiling of 250,000.
How should applicants interpret the listed award ceiling of 250,000?
It should be interpreted carefully in the context of NIH budgeting conventions and the specific NOFO text and application instructions. NIH awards may specify direct cost limits, annual caps, or other budget constraints that can depend on project scope and mechanism details.
What is the overall purpose of this NOFO in the biomarker pipeline?
It is designed as a translational bridge: taking analytically validated assays and generating the clinical validation evidence and cross-lab confidence needed for reliable use in future clinical trials, observational studies, and population research.
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| Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) Apply for PAR 23 313 Funding Number: PAR 23 313 Agency: National Institutes of Health Category: Education, Health Funding Amount: $275,000 |
| Single Source: AIDS and Cancer Specimen Resource (ACSR; UM1 Clinical Trials Not Allowed) Apply for RFA CA 23 043 Funding Number: RFA CA 23 043 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advancing Genomic Medicine Research (R01 Clinical Trial Optional) Apply for RFA HG 23 032 Funding Number: RFA HG 23 032 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities (UG3/UH3, Clinical Trial Required) Apply for PAR 24 053 Funding Number: PAR 24 053 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Advancing Genomic Medicine Research (R21 Clinical Trial Optional) Apply for RFA HG 23 033 Funding Number: RFA HG 23 033 Agency: National Institutes of Health Category: Education, Health Funding Amount: $250,000 |
| Rural Community-Centered Drug Misuse Prevention and Harm Reduction Research: Addressing Implementation, Dissemination, and Equity Challenges across the Continuum of Care (R61/R33 Clinical Trial Only) Apply for RFA DA 24 036 Funding Number: RFA DA 24 036 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies (R61/R33 Clinical Trials Optional) Apply for PAR 24 062 Funding Number: PAR 24 062 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| National Drug Early Warning System Coordinating Center (U01 Clinical Trial Not Allowed) Apply for RFA DA 25 029 Funding Number: RFA DA 25 029 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Required) Apply for RFA DA 25 027 Funding Number: RFA DA 25 027 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Not Allowed) Apply for PAR 23 286 Funding Number: PAR 23 286 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Basic Experimental Studies with Humans Required) Apply for PAR 23 288 Funding Number: PAR 23 288 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Clinical Trial Required) Apply for PAR 23 287 Funding Number: PAR 23 287 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Nursing Research Education Program in Firearm Injury Prevention Research: Short Courses (R25 Independent Clinical Trial Not Allowed) Apply for PAR 24 061 Funding Number: PAR 24 061 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Adolescent Overdose Prevention and SUD Treatment Initiative (R21 - Clinical Trial Not Allowed) Apply for RFA DA 25 030 Funding Number: RFA DA 25 030 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Adolescent Overdose Prevention and SUD Treatment Initiative (R34 - Clinical Trial Optional) Apply for RFA DA 25 031 Funding Number: RFA DA 25 031 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) Apply for RFA CA 24 010 Funding Number: RFA CA 24 010 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Innovative Molecular and Cellular Analysis Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed) Apply for RFA CA 24 008 Funding Number: RFA CA 24 008 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (P30 Clinical Trial Optional) Apply for RFA CA 24 015 Funding Number: RFA CA 24 015 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Revision Applications for Incorporation of Novel NCI-Supported Technology to Accelerate Cancer Research (P50 Clinical Trial Optional) Apply for RFA CA 24 014 Funding Number: RFA CA 24 014 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) Apply for RFA CA 24 011 Funding Number: RFA CA 24 011 Agency: National Institutes of Health Category: Education, Health Funding Amount: $300,000 |
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