Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) | PAR 23 314

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.

• 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.

Apply for PAR 23 314

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