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

Open

National Institutes of Health

Deadline: Jun 25, 2026federal

Updated: Oct 30, 2025

Summary

The purpose of this grant is to facilitate the analytical validation of candidate biomarkers for neurological diseases by rigorously evaluating detection methods and their performance characteristics in accordance with FDA guidelines. Eligible applicants include small businesses, while non-domestic entities and foreign components of U.S. organizations are not eligible to apply. For application details, refer to the full opportunity announcement, and inquiries can be directed to NIH Grants Information at grantsinfo@nih.gov.

Full Description

Description

(Reissue PAR-21-057) The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Eligibility

Eligible applicants

Business

  • Small businesses

Additional information

Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Apply on official siteUpdated Oct 30, 2025

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