Assay Validation For High Quality Markers For NCI-Supported Clinical Trials (UH2/UH3)

The purpose of this Funding Opportunity Announcement (FOA) is to improve the development and validation of molecular diagnostics for the treatment, control, or prevention of cancer. This FOA includes, but is not limited to, the validation of prognostic, predictive or response markers for treatment and markers for cancer control or prevention trials. Applicants should have an assay that works in human samples and whose importance is well justified for development into a clinical assay. The UH2 phase of this FOA supports analytical validation of assays for these markers that must be achieved within two years before an assay may undergo clinical validation. The UH3 phase of this FOA supports the clinical validation of established assays for up to three years using specimens from retrospective or prospective studies from NCI-supported or other clinical trials. In both the UH2 and UH3 phases, clinical laboratory staff, technical and other needs must be an integral part of the application. Assays proposed for this FOA may be used to validate existing assays for use in other cancer clinical trials, observational studies or populations. Projects proposed for this FOA will require multi-disciplinary interaction and collaboration among scientific investigators, clinicians, statisticians and clinical laboratory scientists and staff. This FOA is not intended to support trials that assess the clinical utility of a marker/assay but is intended to develop assays to the point where their clinical utility could be assessed in other trials. Investigators responding to this FOA must address both UH2 and UH3 phases.