Simpler Grants.gov #PAR-25-055

NIH Solicitation: Clinical Validation of Biomarkers for Neurological Disorders

This opportunity from the National Institutes of Health (NIH) supports clinical validation of candidate biomarkers for neurological or neuromuscular disorders. - Government Buyer: - National Institutes of Health (NIH) - Products/Services Requested: - Clinical validation services for strong candidate biomarkers - Focus on rigorous validation of biomarker measurements in clinical populations - Must align with FDA guidelines for biomarker validation - Assumes candidate biomarker and detection technology are already identified and analytically validated - OEMs and Vendors: - No specific OEMs or vendors are named, as this is a research grant opportunity - Unique or Notable Requirements: - Applicants must have an identified and analytically validated biomarker and detection method - No cost sharing or matching required - Broad eligibility for educational, governmental, nonprofit, and business entities, but excludes non-domestic organizations - Emphasis on FDA guideline alignment and clinical context of use - Place of Performance: - National Institutes of Health (federal office)

Description

This Program Announcement (PAR) aims to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. The goal is to rigorously validate biomarker measurements within the clinical population to establish predictive values consistent with FDA guidelines. It assumes a candidate biomarker has been identified, detection technology developed and validated, and the clinical need and context of use identified. The funding instrument is a cooperative agreement with no cost sharing required.

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