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This document is a Notice of Funding Opportunity (NOFO) for the Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed) federal grant opportunity.

The NOFO aims to accelerate the adoption and validation of molecular/cellular/imaging markers and assays for various cancer-related applications, including detection, diagnosis, prognosis, monitoring, and prediction of treatment response or resistance. It supports the validation of pharmacodynamic markers and markers of toxicity. Applicants must have analytically validated assays ready for clinical validation. The UH3 mechanism will provide funding for up to 3 years to validate these established assays using specimens from retrospective or prospective clinical trials or studies. Projects will require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended for early-stage technology development or the conduct of clinical trials.

The federal agency responsible for this opportunity is the Department of Health and Human Services National Institutes of Health (NIH), and the funding is provided under the Cancer Detection and Diagnosis Research program (CFDA 93.394). Eligible applicant types include city/township governments, small businesses, higher education institutions, nonprofit organizations, and various other entities.