The NIH’s funding opportunity (PAR-24-304) supports revisions to existing NIH R01 research grants to accelerate clinical validation of biomarker assays for cancer-related applications. This opportunity, managed by the National Cancer Institute (NCI), focuses on the adaption and validation of biomarkers for cancer detection, diagnosis, prognosis, monitoring, and treatment response prediction. It encourages projects that leverage existing, well-annotated specimens from NCI-supported or other clinical trials to support clinical validation. This NOFO does not fund early-stage development or clinical trials but is intended to advance biomarkers to the stage where they can be integrated into clinical research as investigational tools.

Eligible applicants include a broad range of entities, such as higher education institutions, government agencies, nonprofits, for-profit organizations, tribal organizations, and minority-serving institutions like HBCUs. Non-U.S. entities are not eligible to apply directly but may be included as components in U.S.-based projects.

Applications are due by October 14, 2026, with archiving on November 19, 2026. This grant does not require cost-sharing, and specific funding limits are not disclosed. Applicants are encouraged to include multidisciplinary teams with scientific investigators, clinicians, and statisticians to enhance assay validation for clinical use. Further details are available in the NIH announcement, and NIH Grants Information can provide additional assistance.