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

The Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders grant (U01 Clinical Trial Optional) is being reissued as PAR-21-056. This program wishes to facilitate the analytical validation of potential biomarkers for neurological diseases and conditions. Its ultimate objective is to ensure the thorough validation of analytical methods used in biomarker measurements. In order to achieve this, an evaluation of the detection method, the performance characteristics, and the optimum conditions required for consistent reproducibility and accuracy (as per FDA guidelines) will be conducted. Please note that this program is built on the assumption that a potential biomarker has already been identified, the technology for the detection method has been developed, and the context in which the research and/or potential clinical use have been identified.