Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Accelerate validation of cancer markers and assays for detection, prognosis, treatment response, and toxicity, supporting marker integration into clinical studies.
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)
Funding Amounts: Up to $250,000 direct costs per year for up to 3 years (UH3 mechanism; cooperative agreement).
Summary: Supports clinical validation of analytically validated cancer biomarker assays for integration into clinical studies, not for early-stage assay development or clinical trials.
Key Information: Clinical trials are not allowed; applicants must have analytically validated assays ready for clinical validation.
Description
This opportunity, offered by the National Cancer Institute (NCI) at NIH, aims to accelerate the clinical validation of molecular, cellular, or imaging markers (biomarkers) and their associated assays for cancer detection, diagnosis, prognosis, monitoring, prediction of treatment response or resistance, and for cancer prevention and control. The program supports the validation of pharmacodynamic and toxicity markers as well.
Applicants must already have an assay (or assays) that has been analytically validated in specimens similar to those intended for clinical use. The focus is on moving these assays toward readiness for use in clinical trials or studies, not on early-stage assay development or biomarker discovery.
The funding mechanism (UH3) provides up to three years of support for clinical validation using specimens from retrospective or prospective clinical studies. Projects may also address harmonization and reproducibility of assays across multiple clinical laboratories. Multidisciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists is required.
Note: This opportunity does not support the conduct of clinical trials or early-stage technology development.
