Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) (351913)

The purpose of this Program Announcement (PAR) is to support the clinical validation of strong candidate biomarkers for neurological diseases and conditions. The primary goal is to encourage the rigorous validation of biomarker measurements within clinical populations to determine the biomarkers' positive and negative predictive values, in alignment with FDA guidelines. It specifically targets projects where:

• A candidate biomarker has already been identified,
• A detection method technology has been developed and analytically validated, and
• The research and/or clinical need and potential context of use for the biomarker has been established.