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

The National Cancer Institute (NCI) is soliciting 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. The applicants have the option of submitting either a biphasic UH2/UH3 application for 5 years or a monophasic standalone UH3 application for 3 years to support clinical validation of established assays. • The UH2 phase will support analytical validation of assays for the markers, which must be achieved within 2 years before assays may undergo clinical validation. • The UH3 phase will support clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. • Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. • This NOFO may be used to validate existing assays for use in other clinical trials, observational studies, or population studies. • 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.