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Analytical 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 support the analytical validation of methods for measuring biomarkers related to neurological and neuromuscular disorders, aimed at enhancing clinical trials and practice. Eligible applicants include private and public higher education institutions, small businesses, various nonprofit organizations, and government entities at multiple levels. Application details are not specified in the provided text, but interested parties can contact NIH Grants Information for further inquiries.

Full Description

Description

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. Multi-site applications are expected but not required.

Eligibility

Eligible applicants

Education

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

Business

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

Nonprofit

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

Government

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

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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