Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) | PAR 20 313

Opportunity Information: Apply for PAR 20 313

The National Cancer Institute (NCI) funding opportunity "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)" supports projects that move promising cancer biomarkers and the assays used to measure them closer to real-world clinical and research use. The focus is on validating molecular, cellular, and imaging markers for major cancer applications such as detection and diagnosis, prognosis, disease monitoring, and predicting response or resistance to therapy. It also explicitly includes biomarkers used in cancer prevention and control, along with pharmacodynamic markers (signals that a drug is having its intended biological effect) and markers that indicate toxicity or adverse effects. The overall intent is to improve the quality and reliability of tests that can be used in NCI-supported trials and studies, so that biomarker-driven decisions and endpoints are based on assays that are proven to be accurate and reproducible.

This FOA is structured as a two-stage cooperative agreement using the UH2/UH3 mechanism, meaning there is an initial phase focused on analytical validation followed by a second phase focused on clinical validation, with progression dependent on meeting predefined milestones. In the UH2 phase, which lasts up to two years, the emphasis is on analytical validation: demonstrating that the assay performs well from a laboratory measurement standpoint. This typically involves establishing performance characteristics like accuracy, precision, reproducibility, sensitivity, specificity, limits of detection and quantification, linearity, robustness to variations in handling, and overall reliability when run on human specimens. A key expectation is that applicants are not starting from scratch; they should already have assays that work on human samples and can make a strong case for why the marker and assay are important and ready to be developed into a clinically useful test.

If the project successfully completes UH2 milestones, it can transition into the UH3 phase for up to three additional years. UH3 supports clinical validation, which is about demonstrating that an analytically sound assay is meaningfully associated with a clinically relevant outcome or state. This phase uses well-annotated biospecimens tied to clinical data from retrospective or prospective clinical trials or studies, allowing teams to test whether the biomarker readout can reliably inform a clinical purpose such as risk stratification, outcome prediction, response monitoring, or identifying resistance. The FOA also makes clear that projects can validate existing assays for use in other NCI cancer clinical trials, observational studies, or population studies, so the work is not limited to entirely new tests. Importantly, even though clinical validation is supported, the FOA states "Clinical Trial Not Allowed," which signals that applicants should not propose prospective interventional clinical trials as part of the funded work; instead, the validation should rely on existing or non-interventional study resources and biospecimen collections.

A notable programmatic priority is harmonization and reproducibility across clinical laboratories. Many biomarker assays fail to translate because results vary from one lab to another due to differences in platforms, protocols, reagents, calibration, data processing, or interpretation. This FOA encourages efforts that test and improve cross-laboratory performance, including multi-site comparisons, standard operating procedures, quality control systems, and methods that make results comparable across settings. It also highlights the growing need for assays that measure multiple markers at once, especially as standard cancer treatments like chemotherapy and radiation are increasingly combined with immunotherapies. In practical terms, this can include panels that combine tumor-intrinsic markers with immune markers, or multiplexed assays that support a more complete picture of tumor and host response.

Because the work spans laboratory science, clinical relevance, and rigorous quantitative evaluation, the FOA expects multidisciplinary teams. Competitive projects will typically involve close collaboration among biomarker scientists, oncologists and other clinicians who understand the intended use context, statisticians who can design robust validation plans and avoid common biases, and clinical laboratory scientists who can ensure the assay is feasible, controlled, and potentially transferable to clinical-grade workflows. The cooperative agreement structure also implies substantial program involvement, with NCI engagement in milestone-driven oversight and coordination.

Eligibility is broad across U.S.-based organizations and can include state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, among others, including certain tribal entities and housing authorities. The FOA also explicitly names a range of institution types as eligible applicants, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and U.S. territories or possessions. At the same time, it restricts foreign involvement: non-U.S. entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

In the source data, the opportunity is listed as PAR-20-313, administered by the National Institutes of Health (NIH) through NCI, with a cooperative agreement funding instrument and an activity area categorized under education and health (CFDA 93.394). The original closing date shown is 2023-10-10. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants need to consult the full FOA text for budgeting expectations, project period limits, and any caps or recommended ranges.

• 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 2020-10-13.
• Applicants must submit their applications by 2023-10-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 20 313

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