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

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. • The funding opportunity is for a U01 Clinical Trial Optional, which typically has a project period of up to 5 years. • The award ceiling and floor are not specified, but the funding instrument is a Cooperative Agreement. • Eligible applicants include public and state controlled institutions of higher education, private institutions of higher education, small businesses, and others. • The application due date is June 22, 2026.