Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) | PAR 23 313

Opportunity Information: Apply for PAR 23 313

This funding opportunity, titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)" (PAR-23-313), is a National Cancer Institute (NCI) cooperative agreement meant to push promising cancer biomarkers and their assays closer to real clinical use. The central goal is to support rigorous validation of molecular, cellular, and imaging markers for a wide range of cancer applications, including detection, diagnosis, prognosis, disease monitoring, and predicting response or resistance to therapy. It also explicitly welcomes work on biomarkers used in prevention and cancer control settings, as well as pharmacodynamic markers (to show that a drug is hitting its intended target or pathway) and markers of toxicity (to help anticipate or measure harmful effects of treatment). A key expectation is that applicants are not starting from scratch: proposed assays should already work on human samples and have a strong, well-supported rationale for why they matter and why they are ready to be advanced toward clinical assay development.

The award is structured as a two-phase UH2/UH3 program with clear go/no-go progression. The UH2 phase focuses on analytical validation and must be completed within two years. This is the stage where the assay itself is stress-tested and characterized from a laboratory performance standpoint, so that it is reliable enough to justify moving into studies that evaluate clinical performance. Only after the assay meets the analytical validation benchmarks does the project transition to the UH3 phase. The UH3 phase supports clinical validation for up to three years, typically using well-annotated biospecimens linked to outcomes and clinical data from retrospective or prospective clinical trials or other clinical studies. The emphasis here is determining how well an analytically sound assay performs in a clinical context, such as whether it meaningfully stratifies patients, predicts therapeutic benefit or resistance, tracks disease course, or supports prevention/control decision-making.

A notable feature of this NOFO is its alignment with current treatment realities, where chemotherapy and radiation are increasingly combined with immunotherapies. Because of that, the NCI is open to projects that develop and validate assays measuring multiple markers at the same time, including immune markers, as long as the approach remains grounded in a clear clinical use case. The NOFO also supports efforts to harmonize clinical laboratory tests, including evaluating assay performance and reproducibility across multiple clinical laboratories. That multi-site reproducibility angle matters because an assay that works in one lab but cannot be replicated elsewhere is unlikely to become a dependable tool for large studies or broader clinical adoption.

Because it is a cooperative agreement, applicants should expect substantial involvement from the NIH/NCI program side compared with a standard research grant. Projects are expected to be team-based and multidisciplinary, bringing together expertise such as basic and translational scientists, oncologists and disease-area clinicians, statisticians, and clinical laboratory scientists. The overall intention is to ensure assays are validated with the level of rigor and operational realism needed for use in NCI-supported cancer treatment, prevention, and control trials and studies. Although this NOFO does not allow clinical trials by the applicant under this mechanism, it does encourage leveraging biospecimens and data from existing or planned trials and studies for the validation work.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The NOFO also calls out additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions and non-U.S. components of U.S. organizations are not eligible to apply, but foreign components (as defined by NIH policy) are allowed, meaning limited parts of the work can be done abroad if they meet NIH requirements and are justified.

Administrative details provided include that the sponsoring agency is NIH (specifically NCI), the instrument is a cooperative agreement, and the CFDA number is 93.394. The listed original closing date is 2026-10-14. The opportunity includes an award ceiling of $275,000 (as provided in the source data), and it is categorized under education and health. Overall, the program is designed to bridge the common gap between a promising biomarker assay that appears to work and a clinically credible assay that is analytically sound, clinically validated, and reproducible enough to be trusted in larger NCI-supported cancer 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 (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 2023-11-01.
• 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 $275,000.00 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 23 313

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