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: February 21, 2025 | June 20, 2025 | February 20, 2026 | June 22, 2026
Funding Amounts: No budget cap; budgets should reflect actual project needs | Maximum project period: 4 years
Summary: Supports rigorous analytical validation of biomarker measurement methods for neurological or neuromuscular disorders for use in clinical trials or clinical practice.
Key Information: Non-domestic (non-U.S.) entities are not eligible to apply; foreign components are allowed.
Description
This program supports research projects focused on the analytical validation of methods used to measure biomarkers relevant to neurological or neuromuscular disorders. The objective is to rigorously evaluate the performance of biomarker detection methods—such as accuracy, precision, reportable range, and analytical sensitivity and specificity—across multiple sites and operators. Projects must justify the unmet need for the biomarker(s) and specify one or two contexts of use (e.g., diagnostic, prognostic, monitoring). Multi-site applications are encouraged but not required.
The initiative is designed to help bridge the gap between biomarker discovery and clinical implementation, enabling biomarkers to be used in clinical trials or routine practice. Activities may include optimizing detection methods, establishing reference intervals, and implementing quality control procedures. The program is open to both clinical trial and non-clinical trial applications.
