Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) | PAR 25 075

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.

• 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.

Apply for PAR 25 075

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