The National Institutes of Health (NIH), through the National Cancer Institute (NCI), is offering a Notice of Funding Opportunity (NOFO) titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer," aimed at accelerating the validation of biomarkers and assays for cancer-related applications. This funding opportunity focuses on projects that have already analytically validated assays, supporting their clinical validation over a maximum period of three years, with the goal of integrating these assays into future clinical trials and studies. The initiative is crucial for enhancing cancer detection, diagnosis, prognosis, and treatment response, ultimately improving patient outcomes through validated and harmonized assays. Interested applicants can apply for funding up to $250,000, with the application period opening on January 19, 2024, and closing on October 14, 2026. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.

PAR-23-314-Full-Announcement.html

PAR-23-314.html

The National Institutes of Health (NIH), through the National Cancer Institute (NCI), is issuing a Notice of Funding Opportunity (NOFO) aimed at accelerating the validation of high-quality biomarkers and assays for cancer detection, diagnosis, prognosis, and treatment response. This funding opportunity (PAR-23-314) is a reissue of a previous announcement (PAR-20-314) and is intended for applications that support the clinical validation of established assays over a maximum period of three years. Eligible applicants include higher education institutions, nonprofit organizations, and governmental agencies, among others. The funding mechanism includes cooperative agreements that involve substantial NIH scientific support. The emphasis is on projects that already have analytically validated assays, with a goal to integrate these assays into future clinical trials. Importantly, the NOFO excludes support for early-stage technological developments or conventional clinical trials, focusing instead on optimizing existing assays for clinical contexts. Key dates include an opening date for submissions on January 19, 2024, and the application period expires on October 15, 2026. This opportunity aligns with the NIH's objective of enhancing cancer research and treatment methodologies, ultimately aiming to improve patient outcomes through validated and harmonized assays.

https://grants.nih.gov/grants/guide/pa-files/PAR-23-314.html

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and 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 NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). 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 UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other 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 interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

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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