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

Open

National Institutes of Health

Deadline: Jun 22, 2026federal

Updated: Oct 30, 2025

Summary

The purpose of this grant is to facilitate the clinical validation of candidate biomarkers for neurological diseases, ensuring they meet FDA guidelines for predictive values. Eligible applicants include public and private educational institutions, government entities, nonprofits, and for-profit organizations, with specific inclusions for various minority-serving institutions. Application details are not provided in the description, but interested parties can contact NIH Grants Information for further inquiries.

Full Description

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker 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 analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Eligibility

Eligible applicants

Education

  • Public and state institutions of higher education
  • Independent school districts
  • Private institutions of higher education

Government

  • Federally recognized Native American tribal governments
  • Public and Indian housing authorities
  • County governments
  • City or township governments
  • Special district governments
  • State governments

Nonprofit

  • Nonprofits non-higher education without 501(c)(3)
  • Nonprofits non-higher education with 501(c)(3)
  • Other Native American tribal organizations

Business

  • For-profit organizations other than small businesses
  • Small businesses

Miscellaneous

  • Other

Additional information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; 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, are 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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