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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 (U44 Clinical Trial Optional)

Closes 11/17/2025$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. 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. • The opportunity is open to various applicant types, including small businesses, public housing authorities, Native American tribal organizations, and more. • The funding instrument for this opportunity is a Cooperative Agreement. • The opportunity is listed under the health category. • The expected application count is 100, and the expected application size is 0.

Attached files

Contact

[email protected]

Key dates

Opened
1/22/2024
Closes
11/17/2025

Last updated

Details

Type
Grants Notice
Industry
Healthcare and Medical Services
NAICS
541710
Solicitation №
PAR-24-096

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 estimated that the award amount will likely be in the range of $500,000 to $2 million, considering the funding instrument is a Cooperative Agreement and the opportunity is focused on clinical validation of a candidate biomarker. The actual budget will depend on various factors, including the applicant's proposal, the scope of work, and the NIH's budget for the program.

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