Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)
Accelerate clinical translation of NCI-supported biomarker assays for cancer detection, prognosis, and treatment response validation.
Funder: National Institutes of Health
Due Dates: July 11, 2025 | October 15, 2025 | February 13, 2026 | July 10, 2026 | October 14, 2026
Funding Amounts: Up to $150,000 in direct costs per year; max project period 3 years; cannot exceed parent R01 end date.
Summary: Supports revision applications to clinically validate NCI-supported biomarker assays for cancer detection, prognosis, and treatment response.
Key Information: Only for active NCI R01 projects with ≥2 years remaining; no clinical trials or early-stage technology development.
Description
This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds revision applications to accelerate the clinical validation of molecular, cellular, or imaging biomarker assays developed under currently funded NCI R01 research projects. The goal is to adapt and validate these assays for use in cancer detection, diagnosis, prognosis, monitoring, prediction of treatment response, and cancer prevention/control. The program is not intended for early-stage technology development or for conducting clinical trials, but rather for advancing assays to the point where they are ready for integration into clinical trials as investigational tools.
Projects may include acquisition of well-annotated specimens from NCI-supported or other clinical trials or cohorts for assay validation. Multidisciplinary collaboration is strongly encouraged, including scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff.
