Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
This grant supports validation of cancer markers and assays for research to improve cancer detection, diagnosis, treatment, prevention, and control.
Funder: National Institutes of Health
Due Dates: June 11, 2025 (New) | July 11, 2025 (Renewal/Resubmission/Revision) | October 15, 2025 (New, Renewal/Resubmission/Revision) | February 13, 2026 (New, Renewal/Resubmission/Revision) | June 10, 2026 (New) | July 10, 2026 (Renewal/Resubmission/Revision) | October 14, 2026 (New, Renewal/Resubmission/Revision) | Expires October 15, 2026
Funding Amounts: Up to $275,000 direct costs total for UH2 phase (max $200,000/year, up to 2 years); up to $250,000 direct costs/year for UH3 phase (up to 3 years)
Summary: Supports analytical and clinical validation of molecular, cellular, or imaging assays/biomarkers for cancer detection, diagnosis, prognosis, monitoring, and treatment response, to enable their use in clinical studies.
Key Information: Clinical trials are not allowed; projects must address both UH2 (analytical) and UH3 (clinical) validation phases; foreign organizations are not eligible to apply, but foreign components are allowed.
Description
This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds the analytical and clinical validation of molecular, cellular, or in vitro imaging markers (biomarkers) and assays for cancer research. The goal is to support the development of robust, validated assays that can be used in NCI-supported clinical trials, observational studies, or population studies for cancer detection, diagnosis, prognosis, monitoring, prediction of treatment response or resistance, and cancer prevention/control.
The program uses a two-phase cooperative agreement mechanism (UH2/UH3):
- UH2 phase (up to 2 years): Analytical validation of assays, including accuracy, precision, sensitivity, specificity, reportable range, reference intervals, and quality control.
- UH3 phase (up to 3 years): Clinical validation of analytically validated assays using well-annotated biospecimens from retrospective or prospective clinical studies.
Projects may also focus on harmonizing laboratory tests and evaluating assay performance and reproducibility across multiple clinical laboratories. The program is not intended for early-stage technology development or for conducting clinical trials, but rather for bringing existing assays to the point where they are ready for integration into clinical research.
Multi-disciplinary collaboration is required, involving scientific investigators, oncologists, statisticians, and clinical laboratory scientists.
