The National Institutes of Health (NIH) is offering a funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer," aimed at supporting the validation of biomarkers and related assays for cancer detection, diagnosis, prognosis, and treatment monitoring. This initiative, managed by the National Cancer Institute (NCI), is structured in two phases: the UH2 phase focuses on analytical validation of assays to be completed within two years, while the UH3 phase supports clinical validation for up to three years, emphasizing the need for multidisciplinary collaboration among researchers and clinicians. With an award ceiling of $275,000 for the UH2 phase and up to $250,000 per year for the UH3 phase, interested applicants must submit their proposals by October 14, 2026, and can direct inquiries to grantsinfo@nih.gov for further information.

PAR-23-313-Full-Announcement.html

PAR-23-313.html

The National Cancer Institute (NCI) invites applications for the funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer." This initiative aims to support the validation of molecular, cellular, and imaging markers (biomarkers) and related assays for cancer detection, diagnosis, prognosis, treatment monitoring, and prevention. The funding mechanism operates in two phases: the UH2 phase focuses on analytical validation of assays within two years, while the UH3 phase supports clinical validation for up to three years. Eligible applicants include higher education institutions, nonprofits, and local governments. Applications must demonstrate analytical and clinical validation capabilities, addressing specific milestones for transitioning between phases. The initiative emphasizes teamwork among oncologists, statisticians, and laboratory scientists to ensure the successful integration of validated assays into clinical studies. Award amounts for the UH2 phase can reach $275,000, while the UH3 phase allows up to $250,000 per year. The NOFO is designed to foster advancements in cancer research and treatment through structure and rigorous validation of biomarkers and assays.

https://grants.nih.gov/grants/guide/pa-files/PAR-23-313.html

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as &quot;markers&quot; or &quot;biomarkers&quot;) 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. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. 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 the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer 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 multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist.

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

NIH Grants Information&lt;br/&gt;grantsinfo@nih.gov

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