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

Solicitation PAR-28-042, issued by the National Institutes of Health under the Department of Health and Human Services, is a funding opportunity designed to support the analytical and clinical validation of molecular, cellular, and imaging biomarkers and assays for cancer. The program focuses on tools for cancer detection, diagnosis, prognosis, monitoring, and the prediction of treatment response or toxicity. Funding is available through either a phased UH2/UH3 mechanism or a standalone UH3 mechanism to facilitate laboratory optimization and clinical validation using human samples. Key deliverables include the demonstration of assay results associated with clinical endpoints, the establishment of statistical cut-off values, and the definition of sensitivity and specificity. All clinical laboratories must adhere to CLIA, GLP, or ISO 17025 standards. Awards are determined via a peer review system based on an overall impact score, evaluating the importance of the research, rigor and feasibility of the approach, and the expertise of the investigators and their environment. Specific evaluation criteria include the clarity of milestones for transitioning from UH2 to UH3 phases and the adequacy of commercialization plans. Eligible applicants include small businesses, for-profit organizations, higher education institutions, and 501(c)(3) nonprofits. Applicants must maintain active registrations in SAM.gov, eRA Commons, and Grants.gov. Additionally, recipients must comply with strict cybersecurity incident reporting requirements, notifying the agency within 48 hours of discovery, and ensure all human subject protocols are reviewed by an Institutional Review Board or Independent Ethics Committee.