Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)

The National Institutes of Health (NIH) has announced a funding opportunity for the analytical validation of biomarkers for neurological or neuromuscular disorders through the "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders" program (PAR-25-050). The initiative aims to rigorously evaluate methods for measuring biomarkers to ensure their accuracy, precision, and relevance for clinical use. This funding opportunity, offered by the National Institute of Neurological Disorders and Stroke (NINDS), supports applications proposing multi-site studies but also permits single-site projects with justification. The NOFO invites applications from diverse organizations, including higher education institutions, nonprofits, small businesses, and local governments. The program is intended to bridge the gap between biomarker discovery and clinical application by addressing the unmet need for rigorous analytical validation of biomarkers. Proposed projects should focus on one or two specific contexts of use, which may include diagnostic, monitoring, prognostic, or safety applications. Activities supported include optimizing detection methods, establishing reference intervals, and implementing quality control procedures. The program also encourages collaborative, multidisciplinary teams to foster innovation and address complex challenges in biomarker validation. Funding levels are not capped but must reflect the actual needs of the proposed project. The maximum project period is four years. Applications are required to include a detailed Plan for Enhancing Diverse Perspectives (PEDP), outlining strategies to promote inclusivity and diversity in the research team, study population, or methodologies. This plan will be assessed as part of the peer review process. Additionally, the program encourages leveraging existing resources, such as biospecimens or data repositories, to enhance the feasibility and impact of the research. Eligible applicants must register with the System for Award Management (SAM.gov), obtain a Unique Entity Identifier (UEI), and complete other NIH-specific registrations before submission. Application packages should be prepared using the NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution. Key application components include a research strategy addressing the clinical context, unmet need, and validation methods, as well as a timeline with measurable milestones and a team management plan. Applications will be evaluated based on their scientific and technical merit, including rigor, feasibility, and potential impact. Priority will be given to projects addressing critical program gaps, biomarkers with strong biological rationales, and applications that clearly demonstrate the clinical utility of the biomarker. Letters of support and intellectual property plans are required where applicable. Deadlines for application submissions are February 21, 2025; June 20, 2025; February 20, 2026; and June 22, 2026. Applicants are encouraged to submit their materials early to address potential submission errors. The earliest anticipated start date for awarded projects is December 2025. For questions or assistance, prospective applicants can contact NIH program staff or refer to the NIH application guide.