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

The National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment. This Funding Opportunity Announcement (FOA) will support investigator-initiated research for both analytical and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. The UH2 phase supports analytical validation of assays, which must be achieved within 2 years, and the UH3 phase supports clinical validation of analytically validated assays for up to 3 years. • The opportunity is open to various types of organizations, including non-profits, state governments, public and state-controlled institutions of higher education, and small businesses. • Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. • The NCI will support the validation of pharmacodynamic markers and markers of toxicity. • Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity.