Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
This grant supports validating a biomarker for neurological/neuromuscular disorders and method(s) for clinical use through accuracy and precision testing.
Funder: National Institutes of Health
Due Dates: May 21, 2025 (Letter of Intent) | June 20, 2025 | February 21, 2025 | February 20, 2026 | June 22, 2026 (Full Applications)
Funding Amounts: No budget limit; actual needs should be justified. Maximum project period: 4 years. Cooperative agreement (U01).
Summary: Supports rigorous analytical validation of biomarker measurement methods for neurological or neuromuscular disorders for clinical trial or practice use.
Key Information: Multi-site applications are encouraged but not required; applications must specify context(s) of use and include milestones.
Description
This opportunity from the NIH National Institute of Neurological Disorders and Stroke (NINDS) funds research to conduct rigorous analytical validation of methods for measuring biomarkers relevant to neurological or neuromuscular disorders. The goal is to enable the use of these biomarkers in clinical trials or clinical practice by ensuring the measurement methods are accurate, precise, and robust across sites and operators.
Applicants must justify the unmet need for the biomarker(s) and the measurement method(s), and specify one or two context(s) of use (e.g., diagnostic, prognostic, monitoring). Supported activities include optimizing and evaluating the detection method’s accuracy, precision, reportable range, analytical sensitivity and specificity, and establishing reference intervals and quality control procedures. Multi-site validation is encouraged to ensure reproducibility, but single-site applications are allowed with strong justification.
This program is intended for projects where the biomarker and detection method have already undergone initial development and preliminary evaluation, and are ready for rigorous analytical validation. Earlier-stage biomarker discovery or clinical validation studies should consider companion NOFOs.
