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

The National Cancer Institute (NCI), a component of the National Institutes of Health (NIH), has announced a reissue of its funding opportunity under PAR-24-304. This initiative invites revision applications from currently funded NCI R01 research project awardees. The central goal of this Notice of Funding Opportunity (NOFO) is to accelerate the clinical translation of biomarker assays that were developed through NCI-supported research. The focus lies specifically on the adaptation and clinical validation of molecular, cellular, or imaging-based biomarkers used for cancer detection, diagnosis, prognosis, monitoring treatment response, and informing prevention or control strategies. These assays must be analytically validated or near the completion of such validation to be eligible for further clinical validation under this grant. The funding mechanism is a revision to the existing NIH R01 Research Project Grant and does not allow for clinical trials. Rather than supporting early-stage assay development or new trials, this NOFO funds efforts to validate existing assays using human clinical specimens, moving them closer to deployment in investigational settings. The program encourages multi-disciplinary collaboration among researchers, assay developers, clinicians, statisticians, and laboratory professionals. Projects that aim to standardize or harmonize assay performance across labs are also eligible, even if they require some continued analytical optimization. To be eligible, applicants must have an active R01 grant from NCI with at least two years remaining in the award period, excluding no-cost extensions. The application must demonstrate the assay's clinical relevance and detail its performance metrics, including sensitivity, specificity, accuracy, and reproducibility. The proposed study should also define the clinical context of use and explain the integration of statistical power analyses, sample access strategies, and regulatory considerations. Collaboration with a commercial partner for assay distribution is optional but encouraged. Funding is capped at $150,000 in direct costs per year and the project period cannot exceed three years or extend beyond the end of the parent award. Awards will be granted based on scientific merit, funding availability, and alignment with NCI priorities. The number of awards is contingent on both appropriations and the quality of submissions. Matching funds are not required. Applications are accepted on a rolling cycle with three annual due dates: February 14, July 11, and October 15, continuing through October 14, 2026. Reviews follow standard NIH review and council schedules, and award start dates typically follow several months after submission. Applicants must use ASSIST, Grants.gov Workspace, or institutional S2S systems to prepare and submit applications. Applications must follow NIH guidelines outlined in the Application Guide and conform to the unique specifications of this NOFO. Scientific and administrative questions should be directed to designated NCI contacts, including Dr. Sumana Dey, Dr. Rao Divi, or Dr. Asad Umar, depending on the biomarker application area. For financial inquiries, Shane Woodward is the primary contact at NCI. All applicants must ensure their registrations with SAM.gov, eRA Commons, and Grants.gov are active and compliant before submission. Applications that fail to meet submission requirements or are found to be nonresponsive will not be reviewed. Review criteria include scientific significance, feasibility, innovation, and integration of appropriate personnel and infrastructure.

Applications must include multidisciplinary teams and strong assay validation data; failure to meet formatting or content guidance will result in rejection.