Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
ID: 351912Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity aimed at supporting the analytical validation of candidate biomarkers for neurological and neuromuscular disorders through cooperative agreements (U01). This initiative requires applicants to demonstrate the unmet need for the biomarker(s) and specify their contexts of use, with a strong emphasis on establishing robust analytical validation that addresses accuracy, precision, sensitivity, and specificity across testing sites. The program encourages diverse research teams and mandates a Plan for Enhancing Diverse Perspectives (PEDP) to foster inclusive scientific innovation. Applications are due by June 22, 2026, with no explicit budget limit, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. For more details, please refer to the full announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-24-095.html.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), has issued a funding opportunity (NOFO) aimed at supporting the analytical validation of biomarkers for neurological and neuromuscular disorders. This initiative includes cooperative agreements (U01) for research projects and highlights the necessity for applications to demonstrate the unmet need for the biomarker(s) and specify contexts of use. A critical emphasis is on establishing robust analytical validation that addresses accuracy, precision, sensitivity, and specificity across testing sites. The requirement for a Plan for Enhancing Diverse Perspectives (PEDP) is highlighted, with a focus on fostering inclusive research teams to enhance scientific innovation. Applications must include detailed plans addressing project milestones, management, and collaborative efforts among diverse researchers and institutions. The funding is project period is capped at 4 years with no explicit budget limit, requiring a health and scientifically rigorous rationale for any funding requests. The document outlines comprehensive application procedures, including strict adherence to submission guidelines and the importance of early contact with NIH program staff. Applications not aligned with the scope, including those primarily focused on clinical trials or lacking required components, will be considered non-responsive and withdrawn from review.
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