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Closed on Jun 22, 2026

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

National Institutes of Health · Opportunity number PAR-25-055

Details summarized from the official notice as of Jun 23, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.

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This opportunity is closed as of Jun 22, 2026. It is kept here for reference. See the related open opportunities below, or check the official listing in case the agency posts a new cycle.

Key facts

Opportunity numberPAR-25-055
AgencyNational Institutes of Health
Department of Health and Human Services
Assistance listing (ALN, formerly CFDA)93.853
PostedOct 2, 2024
DeadlineJun 22, 2026
Cost sharing or matching requiredNo
Funding typeCooperative agreement
CategoryHealth
Last updated hereJun 23, 2026

Summary from the notice

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.

Who can apply

The official notice lists these applicant types as eligible:

  • Public and state colleges and universities
  • Independent school districts
  • Federally recognized tribal governments
  • Nonprofits without 501(c)(3) status (other than colleges)
  • Public and Indian housing authorities
  • For-profit organizations other than small businesses
  • Private colleges and universities
  • County governments
  • Nonprofits with 501(c)(3) status (other than colleges)
  • City or township governments
  • Other Native American tribal organizations
  • Small businesses
  • Special district governments
  • Others named in the notice (see the eligibility text)
  • State governments

Who should take a closer look

  • Small businesses
  • Nonprofits
  • Colleges and universities
  • State governments
  • Local governments
  • Tribal governments and organizations
  • Larger for-profit companies

Not listed as eligible

  • Individuals

Unless the eligibility text in the notice names you, this opportunity is probably not for you.

Eligibility details from the notice

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.

Registrations you will likely need

Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.

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