Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
The grant title "Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)" aims to support the clinical validation of already analytically validated biomarkers and assays for cancer detection, diagnosis, and treatment monitoring, ensuring they are reliable and ready for use in clinical studies without conducting new trials.
Description
The NIH’s National Cancer Institute (NCI) funding opportunity (PAR-25-075) supports the clinical validation of high-quality biomarkers for cancer research, specifically for assays already analytically validated in similar specimen types. This UH3 cooperative agreement, which does not allow clinical trials, focuses on biomarkers for cancer detection, diagnosis, prognosis, monitoring, and treatment response. It also includes markers for toxicity and pharmacodynamics, aiming to facilitate their integration into clinical trials and observational studies.
Projects may include assays for multiple markers, such as immune markers relevant in combined cancer therapies involving chemotherapy, radiation, and immunotherapy. The opportunity is ideal for validating assay performance and reproducibility across laboratories, with a focus on established assays that can be harmonized across clinical settings.
Eligible applicants include a broad range of institutions, including higher education institutions, tribal governments, local and state governments, and specific minority-serving institutions like HBCUs. Foreign entities cannot apply directly but may be included as components within U.S.-based applications.
With an award ceiling of $250,000, this grant does not require cost-sharing. Applications are due by October 14, 2026, with more information available on the NIH website. Interested applicants should consult NIH contacts for further guidance.