Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 - Clinical Trials Not Allowed | PAR 18 310

Opportunity Information: Apply for PAR 18 310

The NIH funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 - Clinical Trials Not Allowed)" (Funding Opportunity Number PAR-18-310) is a cooperative agreement designed to speed up the real-world adoption of cancer-related biomarkers and the assays used to measure them. The central goal is to move promising molecular, cellular, and imaging markers closer to routine use in clinical research by supporting the kinds of validation work that allow investigators and clinicians to trust results across sites, instruments, operators, and specimen types. Rather than focusing on discovering new markers, this FOA is about strengthening and standardizing assays that are already sufficiently mature so they can be used confidently in clinical studies.

The program targets assays and markers that serve a broad range of oncology needs. This includes markers for cancer detection and diagnosis (identifying cancer and characterizing it), prognosis (predicting likely disease course), monitoring (tracking disease status over time), and prediction of response or resistance to treatment (helping determine who may benefit from a therapy and who may not). It also explicitly covers markers used in cancer prevention and cancer control. In addition, the FOA includes work on pharmacodynamic markers, which help show whether a drug is having its intended biological effect, and markers of toxicity, which are used to understand or anticipate harmful side effects. A notable emphasis is the increasing complexity of modern cancer therapy, especially the common pairing of chemotherapy and/or radiation with immunotherapies. Because these combination strategies often require a more comprehensive view of tumor biology and immune response, the FOA recognizes that multiple assays measuring multiple markers, including immune markers, may need to be developed and validated in parallel.

A key eligibility and readiness requirement is that applicants must already have an assay (or assays) whose performance has been analytically validated in specimens that are similar to those intended for the assay's eventual clinical use. In other words, this opportunity is not meant for early-stage assay concepts; it is geared toward teams that have already done foundational analytical validation and now need support to confirm robustness, reproducibility, and suitability for use in clinical studies. The "Clinical Trials Not Allowed" designation reinforces that the funded work should not be structured as a clinical trial evaluating interventions or outcomes in the traditional sense, but rather as assay and marker validation activities that enable or improve clinical research.

The funding mechanism is a UH3 cooperative agreement, meaning the NIH is expected to have substantial involvement in the funded projects compared with a standard grant. Cooperative agreements often include coordination with NIH program staff, milestone-driven management, and expectations around data quality, standardization, and deliverables. The opportunity sits within NIH's health mission space (CFDA number 93.394) and is categorized under discretionary funding, with an activity category listed as education and health. The source information indicates an award ceiling of $250,000, and the FOA was created on 2017-10-12, with an original closing date listed as 2020-10-08.

Eligibility is broad across the U.S. research and public health ecosystem. Eligible applicants include various levels of government (state, county, city/township, and special district governments), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations other than small businesses, and small businesses. The FOA also highlights additional applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Federally recognized tribal governments are eligible, and it also notes Indian/Native American Tribal Governments other than federally recognized entities among the other eligible applicants.

Foreign participation is restricted in a specific way. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain foreign collaborators or activities when justified and compliant with NIH policy. This structure allows the program to support globally relevant scientific and technical contributions while keeping the award anchored within eligible U.S. applicant organizations.

Overall, this FOA is best understood as a translational quality-and-readiness program for cancer biomarkers: it supports projects that take already analytically validated assays and push them through the practical validation steps needed for dependable use in clinical studies, including complex multi-marker contexts such as immune monitoring in combination therapy settings, without funding clinical trials themselves.

• 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 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.)
• 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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