Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) | PAR 24 304

Opportunity Information: Apply for PAR 24 304

The NIH National Cancer Institute (NCI) is soliciting revision applications under NOFO PAR-24-304, titled "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)." The core purpose is to speed up the translation of biomarker-related assays and technologies that were previously developed with NIH support so they can move closer to real clinical use. In practice, this funding is meant to help take an already-developed assay and do the additional adaptation and clinical validation work needed so it can credibly function in clinical settings and be ready for inclusion in future clinical trials as an investigational tool.

The scientific focus is on adapting and clinically validating assays that measure molecular, cellular, or imaging biomarkers relevant to cancer. These biomarkers can be aimed at cancer detection and diagnosis, prognosis, monitoring over time (such as tracking disease burden or recurrence), and predicting response to therapy. The NOFO also includes markers used in cancer control and prevention, not just treatment. The emphasis is not on inventing a brand-new biomarker platform from scratch, but on bringing an existing NIH-supported assay across the gap between promising research performance and clinically meaningful, validated performance.

A key feature of the opportunity is support for obtaining and using well-annotated specimens and datasets to conduct clinical validation. Applicants may propose acquiring samples from NCI-supported clinical trials or from other clinical trials, observational cohorts, or research consortia, as long as the materials are appropriately annotated (for example, with clinical outcomes, patient characteristics, treatment details, and relevant covariates). This reflects the reality that strong validation depends on high-quality specimens and reliable clinical context, and that many assay translation efforts stall because those resources are difficult and expensive to access.

The NOFO strongly encourages team science and a multidisciplinary structure. Competitive projects are expected to involve close coordination among assay developers, disease-focused clinicians, clinical laboratory professionals, and statisticians. The notice explicitly highlights the importance of including clinical laboratory scientist(s) and statistical experts as integral members of the team, which signals that NCI is prioritizing rigorous analytical performance work (such as reproducibility, robustness, and clinical laboratory feasibility) as well as sound study design and analysis plans (such as appropriate endpoints, sample size and power reasoning where applicable, bias control, and handling of confounders).

This is not a mechanism for early-stage technology development, nor is it intended to fund the conduct of clinical trials. The award is positioned for the middle-to-late translational phase: taking an assay that already exists and performing the adaptation and validation steps needed so it could realistically be deployed as an investigational assay, tool, or device within future trials or clinical workflows. Also noted in the title is "Clinical Trial Not Allowed," meaning applicants should not propose a study that meets the NIH definition of a clinical trial under this mechanism; the work should stay within assay adaptation and validation activities rather than interventional clinical testing.

In terms of applicant eligibility, the opportunity is broadly open across many organization types. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, small businesses, and certain tribal entities (federally recognized tribal governments and tribal organizations). The NOFO also explicitly calls out additional eligible groups 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, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations.

Administratively, this is an NIH grant opportunity using the R01 activity code as a revision application pathway, with an original closing date listed as 2026-10-14 and a creation date of 2024-10-10. The CFDA (Assistance Listing) number provided is 93.394, and the activity areas are health and education. An award ceiling is not specified in the provided source data, and the expected number of awards is also not listed, which typically means applicants need to rely on the NOFO text and NIH institute funding considerations for budgeting expectations.

Overall, PAR-24-304 is best understood as targeted funding to help mature NIH-supported cancer biomarker assays into clinically credible, analytically and clinically validated tools, using strong specimens and rigorous multidisciplinary methods, without funding early invention work or interventional clinical trial execution.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 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 2024-10-10.
• 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.)
• 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 24 304

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: