Clinical Validation of Biomarkers for Neurological and Neuromuscular Disorders

National Institutes of Health

Description

This grant opportunity aims to support the thorough validation of biomarker tests in clinical settings to confirm their accuracy and reliability, in line with FDA standards. It is intended for biomarkers that have already been identified and have validated detection methods, with an established research or clinical use identified.

The goal of this PAR is to enable the rigorous clinical validation of biomarker measurements within the clinical population of interest to establish the clinical sensitivity and specificity of the biomarker consistent with FDA guidelines. This PAR assumes that a candidate biomarker has already b…

Source

Grant ID

PAR-25-055

Agency

National Institutes of Health

Subcategory/Subagency

National Institute of Neurological Disorders and Stroke

Key Dates

Opportunity Released

October 2, 2024

Open for Submission

October 2, 2024

Submission Deadline

June 22, 2026

Application Window Closes

June 22, 2026

Eligibility

The following categories of applicants are invited to apply:

  • Higher Education Institutions – Public/State Controlled Institutions of Higher Education
  • Higher Education Institutions – Private Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (other than Institutions of Higher Education)
  • For-Profit Organizations – Small Businesses
  • For-Profit Organizations (other than Small Businesses)
  • Local Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Federal Government – Eligible Agencies of the Federal Government
  • U.S. Territory or Possession Governments
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Additional Eligibility Information
Foreign/Non-domestic entities: 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. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. Required registrations (applicant organizations): Must complete and maintain SAM (renew at least annually; domestic orgs receive/maintain a CAGE code), obtain a Unique Entity Identifier (UEI) via SAM, register in eRA Commons (wi…
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