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U.S. National Institutes of Health·United States of America

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

Closes 6/22/2026$500k – $2MGrants Notice
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Description

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. 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 a candidate biomarker has already been identified, detection method technology has already been developed and analytically validated, and the research and/or clinical need and potential context of use has been identified. • The opportunity is open to various types of applicants, including public and state-controlled institutions of higher education, Native American tribal governments, non-profits, and small businesses. • The application deadline is June 22, 2026. • The opportunity is for a cooperative agreement. • The award ceiling and floor are not specified.

Attached files

Contact

[email protected]

Key dates

Opened
1/22/2024
Closes
6/22/2026

Last updated

Details

Type
Grants Notice
Industry
Healthcare and Medical Services
NAICS
541710
Solicitation №
PAR-25-055

Budget estimate

$500,000 – $2,000,000

The budget for this opportunity is not explicitly stated, but based on the information provided, it can be inferred that the award amount will depend on the specific requirements of the clinical validation of the candidate biomarker. The National Institutes of Health typically provides funding for research and development projects, and the award amount can range from a few hundred thousand dollars to several million dollars. A rough estimate for this opportunity could be between $500,000 and $2 million, considering the scope of the project and the funding agency.

AI estimate from the solicitation

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