Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. The applicants have the option of submitting either a biphasic UH2/UH3 (Developmental Cooperative Agreement Phase I/Developmental Cooperative Agreement Phase II) application for 5 years or a monophasic standalone UH3 (Developmental Cooperative Agreement Phase II) application for 3 years to support clinical validation of established assays. The UH2 phase of this NOFO 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 of this NOFO 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. Investigators applying for UH2/UH3 must address both UH2 and UH3 phases, and propose milestones to be accomplished in the UH2 phase for transition to the UH3 phase. Applicants to the stand alone UH3 must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended use of the assay(s) and marker(s).

This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. Investigators applying in response to this NOFO must propose optimizing an existing assay(s) using human specimens in a clinical laboratory into assays that can be used in a clinical trial/study for the treatment, prevention or control of cancer.

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. Projects proposed for this NOFO will require multidisciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. Clinically validated assays are expected to provide new useful tools for cancer risk/survival assessment, precision cancer prevention and control, for guiding cancer therapy decisions, and for better management of cancer patients.

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