Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

The NIH’s National Cancer Institute (NCI) invites applications for assay validation of biomarkers for cancer clinical studies through PAR-25-074. This funding opportunity (UH2/UH3 mechanism) supports research to validate biomarkers used in cancer detection, diagnosis, prognosis, treatment monitoring, and prevention. The aim is to advance assays that are robust and clinically relevant, particularly for predicting response or resistance to treatment. Clinical trials are not allowed for this opportunity, but validated assays may support future NCI-funded clinical trials. The funding involves two phases. The UH2 phase, lasting up to two years, focuses on analytical validation of assays for molecular, cellular, and imaging markers in human samples. Upon meeting validation milestones, successful projects can move to the UH3 phase, which supports clinical validation over three years using biospecimens from clinical trials or studies. This phase enables evaluation of assay performance and reproducibility across multiple laboratories, including validation of pharmacodynamic and toxicity markers. Eligible applicants include institutions of higher education, nonprofits, for-profit organizations, tribal governments, and certain minority-serving institutions such as HBCUs and Hispanic-serving Institutions. While foreign entities cannot apply directly, foreign components are permitted within U.S.-based applications. Applications are due by October 14, 2026, with no cost-sharing requirement. Further information and application instructions are available on the NIH website, and applicants are encouraged to consult NIH contacts for guidance.