Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 - Clinical Trials Not Allowed) | PAR 18 317

Opportunity Information: Apply for PAR 18 317

The National Institutes of Health (NIH) funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 - Clinical Trials Not Allowed)" (Funding Opportunity Number PAR-18-317) is designed to move promising cancer biomarkers and the assays that measure them closer to real-world clinical use. The central goal is to support rigorous validation work for molecular, cellular, and imaging markers that can help with cancer detection and diagnosis, predict patient outcomes (prognosis), track disease over time (monitoring), and anticipate whether a patient will respond to a therapy or develop resistance. The scope also explicitly includes markers relevant to cancer prevention and cancer control, plus pharmacodynamic markers (signals that show whether a drug is hitting its intended target or producing a biological effect) and markers that can indicate toxicity or safety concerns.

A key expectation is that applicants are not starting from scratch: they should already have assays that work on human samples, and there should be a strong, well-argued rationale for why the marker and assay are important enough to justify development into a clinical-grade test. In practical terms, this opportunity is about demonstrating that an assay is reliable, reproducible, and fit-for-purpose when applied to the types of human specimens and study settings encountered in cancer research and, ultimately, clinical workflows. The FOA emphasizes validation rather than discovery, meaning the strongest applications typically center on well-supported markers with evidence suggesting clinical relevance, and then propose a clear plan to confirm performance characteristics and robustness.

The announcement also reflects the direction of modern oncology, where treatments are frequently combined, especially traditional modalities like chemotherapy and radiation with immunotherapies. Because combination regimens can involve multiple biological pathways and immune responses at once, the FOA notes that it can be appropriate to develop and validate multiple assays in parallel, including assays for immune markers. This supports the idea of coordinated assay panels or multi-marker strategies that better capture the complexity of treatment response, resistance, and patient heterogeneity, as long as the work remains focused on validation and not on conducting clinical trials.

Mechanistically, this is a cooperative agreement using the UH2/UH3 phased award structure. That format generally supports a two-stage project: an initial phase (UH2) that focuses on early validation milestones and feasibility, followed by a second phase (UH3) that expands and completes validation activities once predefined milestones are met. Because it is a cooperative agreement, NIH is typically more programmatically involved than under a standard grant, which often translates into closer coordination with NIH staff, milestone-driven management, and an emphasis on achieving defined performance and validation outcomes. The FOA is explicit that clinical trials are not allowed under this opportunity, so applicants must structure projects to avoid interventional clinical trial activities while still using human samples and clinically relevant study materials for assay validation.

Eligibility is broad and includes many common U.S. applicant types such as state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also highlights inclusion of organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, there are important limits related to foreign participation. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions 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, meaning a U.S.-based applicant may include certain foreign elements within the project when justified and compliant with NIH policy, even though a foreign organization cannot be the applicant institution.

From the source details provided, the opportunity is categorized as discretionary funding, uses the cooperative agreement funding instrument, and falls under an education/health activity category with CFDA number 93.394. The sponsoring agency is NIH. The original closing date listed is October 8, 2020, and the opportunity creation date is October 12, 2017. Award ceiling and expected awards are not specified in the provided extract, which usually means applicants need to consult the full FOA text or NIH notices for budget guidance, typical award sizes, and programmatic expectations.

Overall, this FOA is best seen as a translational bridge between biomarker discovery and clinical implementation: it funds the hard, methodical work of proving an assay is dependable on human samples, defining how it performs, and positioning it for use in clinical studies and future clinical testing environments, without crossing into NIH-defined clinical trial activities.

• 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 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 2017-10-12.
• Applicants must submit their applications by 2020-10-08. (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.

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