Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) | PAR 20 314

Opportunity Information: Apply for PAR 20 314

The NIH funding opportunity PAR-20-314, titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)," is designed to move promising cancer biomarkers and their associated assays from the "ready in the lab" stage to the point where they can be credibly used as investigational tools in clinical research. The overall aim is to speed up adoption and rigorous validation of molecular, cellular, and imaging markers that could improve how cancer is detected, diagnosed, and managed. This includes biomarkers for early detection and diagnosis, prognosis, disease monitoring, and predicting whether a patient is likely to respond to treatment or develop resistance. The FOA also explicitly includes support for validating pharmacodynamic markers (signals that a drug is having its intended biological effect) and markers of toxicity (signals that treatment is causing harmful side effects), which are increasingly important as therapies become more complex.

A key requirement is that applicants must already have an assay (or assays) with analytical validation completed in specimens similar to those intended for the eventual clinical use. In other words, the FOA is not meant for inventing a brand-new measurement technology or running exploratory feasibility work. Instead, it targets assays that are already technically characterized (for example, showing acceptable accuracy, precision, sensitivity, specificity, and robustness) and now need clinical validation to demonstrate that the marker readout is meaningfully associated with clinical states or outcomes in relevant patient samples. The program recognizes that modern cancer treatment often combines chemotherapy and radiation with immunotherapies, so it allows and encourages multiplex approaches where multiple markers, including immune-related markers, are developed and validated together when scientifically justified.

Funding is provided through the UH3 cooperative agreement mechanism, reflecting that NIH expects substantial programmatic involvement and coordination during the project period. The UH3 phase under this FOA supports clinical validation of established assays for up to three years. Clinical validation here generally means testing the assay on well-annotated specimens and datasets to show that the biomarker measurement performs reliably and correlates with clinically meaningful endpoints in the intended context of use. The samples can come from retrospective collections or from prospective clinical trials or clinical studies, and the resulting validated assays can be positioned for use in future trials, observational studies, or population studies. Importantly, even though specimens may come from trials, the FOA is explicitly not intended to fund the conduct of clinical trials themselves; it is focused on the assay and biomarker validation work needed so that the assay can later be integrated into clinical studies as an investigational tool.

Another major theme is harmonization and reproducibility, particularly across multiple clinical laboratories. The FOA supports work aimed at standardizing clinical laboratory tests and evaluating how assay performance holds up when transferred between sites. This can include inter-laboratory comparisons, reproducibility testing, and approaches to reduce variability due to differences in instruments, operators, reagents, or workflows. The emphasis on harmonization reflects a practical barrier in biomarker research: even a strong biomarker can fail to translate if different labs cannot produce comparable results.

Because the work spans assay science, clinical oncology, and rigorous study design, the FOA expects multidisciplinary collaboration. Competitive projects will typically involve coordinated effort among biomarker and assay developers, oncologists and disease-area experts, statisticians and methodologists, and clinical laboratory scientists. The goal is to produce validation evidence that is not only scientifically sound but also operationally realistic for use in clinical research settings.

In terms of administrative details, this is a discretionary federal funding opportunity administered by the National Institutes of Health under CFDA 93.394, using a cooperative agreement funding instrument. The opportunity lists an award ceiling of $250,000. Eligible applicants are broad and include many U.S.-based organizations and government entities: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and certain tribal organizations; public housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including entities other than small businesses); and small businesses. The FOA also highlights additional categories of eligible applicants such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and eligible federal agencies. At the same time, it restricts foreign participation: 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.

Finally, the FOA is positioned as a translational bridge: it is meant to take assays that are already analytically validated and push them through the kind of clinical validation and cross-site performance work needed for credible deployment in clinical studies. The intended endpoint is not immediate clinical adoption as a standard-of-care diagnostic, but a level of validation and standardization that makes the assay dependable enough to be used in clinical trials and studies as an investigational assay, supporting better decision-making in cancer research and, ultimately, improved patient outcomes.

• 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 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.)
• 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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