Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) | PAR 24 047

Opportunity Information: Apply for PAR 24 047

The NIH, through the National Cancer Institute (NCI), is offering a grant opportunity (PAR-24-047) that supports revision applications to existing NIH-funded research grants, with the goal of moving promising, NCI-supported biomarker assays closer to real clinical use. The central purpose is to speed up translation of methods, assays, and related technologies that have already been developed under NIH support so they can be adapted and clinically validated for cancer-focused applications. The program is aimed at bridging the common gap between a biomarker assay that works well in a research setting and one that is solid enough, standardized enough, and validated enough to be used as an investigational tool in a clinical trial setting later on.

The scientific focus is on adapting and validating assays tied to molecular, cellular, or imaging biomarkers relevant to cancer. These biomarkers can be intended for cancer detection or diagnosis, for prognosis and risk stratification, for monitoring disease over time, or for predicting treatment response. The NOFO also explicitly includes biomarkers related to cancer control and prevention, which broadens the scope beyond treatment-response markers alone. In practical terms, the work supported here is about demonstrating that the assay performs reliably with clinically relevant samples and under conditions that reflect how it would be used in real-world clinical research workflows.

A key feature of the opportunity is support for obtaining and using well-annotated human specimens, especially from NCI-supported clinical trials and other clinical research resources such as observational cohorts or consortia. The point of using these sample sets is to perform clinical validation in a way that is statistically credible and clinically meaningful. That typically means the specimens have strong associated metadata (for example, diagnosis, stage, treatment, outcomes, timepoints, collection procedures) so the assay results can be evaluated against real clinical endpoints and contexts. The emphasis is not simply on generating more exploratory data, but on producing evidence that the assay is ready to be integrated into clinical research as an investigational assay, tool, or device.

The NOFO strongly encourages multidisciplinary teams and expects applicants to bring together the right expertise to do rigorous validation. Assay developers and basic scientists are expected to work closely with clinicians, clinical laboratory professionals, and statisticians. Clinical laboratory scientists are highlighted because moving an assay toward clinical readiness often requires attention to analytical performance, reproducibility, quality control, pre-analytic variables, and operational workflow considerations. Statistical experts are highlighted because validation depends on sound study design, power calculations, predefined performance metrics, and clear interpretation standards that can withstand scrutiny and support downstream clinical use.

This funding opportunity is not meant for early-stage technology development, and it is not meant to fund the conduct of clinical trials. The work sits in the middle ground: taking something that already exists from NIH-supported research and doing the adaptation and validation steps needed so it can later be used within clinical trials. Importantly, the FOA title specifies "Clinical Trial Not Allowed" for the R01 mechanism in this context, reinforcing that the funded activities should be validation-oriented rather than interventional trial execution.

From an administrative and eligibility standpoint, it is a discretionary NIH grant opportunity within the education and health activity category (CFDA 93.394). A wide range of applicants can apply, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other categories. The opportunity also calls out additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, US territories or possessions, and non-US entities (foreign organizations). This broad eligibility is designed to encourage participation from many sectors that contribute to biomarker development and validation, including organizations with access to unique patient populations, specimen resources, or specialized laboratory expertise.

Key logistical details include an original closing date of 2026-10-13 and an award ceiling listed as $150,000. The opportunity was created on 2023-10-10. Overall, the program is best understood as targeted support for strengthening and clinically validating cancer biomarker assays that have already emerged from NIH-funded research, so they can credibly progress into clinical research pipelines and, ultimately, into settings where they can influence patient care decisions.

• 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 2023-10-10.
• Applicants must submit their applications by 2026-10-13. (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 $150,000.00 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.

Apply for PAR 24 047

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