Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) | PAR 24 098

Opportunity Information: Apply for PAR 24 098

The NIH funding opportunity PAR 24-098, titled "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)," is a small business-focused cooperative agreement designed to move promising neurological and neuromuscular biomarkers closer to real-world clinical and regulatory use by funding rigorous analytical validation. It is a reissue of PAR-21-057 and centers on one specific bottleneck in biomarker development: proving that the measurement method for a biomarker is reliable, accurate, and reproducible under well-defined conditions, in a way that aligns with expectations commonly associated with FDA guidelines for assay performance.

The core purpose of the program is not to discover a new biomarker or invent a new detection technology, but to validate the analytical method used to measure a biomarker that is already considered a strong candidate. The opportunity assumes three things are already in place before an application is submitted: first, the candidate biomarker has already been identified; second, the underlying detection method or technology for measuring it has already been developed; and third, there is already a clear research and/or clinical need for the biomarker along with an identified "context of use" or at least a well-justified potential context of use. In practice, that means applicants should come in with a biomarker and assay that are beyond the exploratory stage, and the work proposed should focus on making the measurement approach robust enough to be trusted across runs, operators, sites, instruments, and sample conditions.

The funded work is expected to address the kinds of performance characteristics that determine whether a biomarker test can be relied on for downstream uses such as clinical research, patient stratification, pharmacodynamic readouts, or eventual clinical decision support. That typically includes evaluating how the detection method behaves under different operating conditions and quantifying key analytical metrics such as accuracy, precision, sensitivity, specificity/selectivity, limits of detection and quantification, linearity and dynamic range, reproducibility, stability, and robustness. The emphasis on "optimal conditions" highlights that NIH is looking for well-controlled method optimization and standardization work that leads to consistent results, not just proof-of-concept measurements.

This is a cooperative agreement (U44), which generally means NIH program staff are expected to have substantial involvement during the project compared with a standard grant. That structure is commonly used when an agency wants active collaboration, milestone-based progress, and close alignment with program goals, especially when the endpoint is a validated tool that others can adopt. The notice states that clinical trials are optional, indicating that while a trial is not required, certain proposals could include clinical elements if they are justified and fit within the analytical validation scope (for example, collecting or using human samples to test assay performance), as long as the central aim remains analytical validation rather than clinical efficacy testing.

Eligibility is limited to small businesses, consistent with the U44 mechanism and its role in bridging research and commercialization-oriented development. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, foreign components may be allowed under NIH policy as defined in the NIH Grants Policy Statement, which typically means a U.S. applicant organization might be able to include certain foreign activities or collaborations when well-justified and compliant, even though the primary applicant must be a U.S. small business.

Administratively, the opportunity is offered by the National Institutes of Health, categorized under Health (CFDA 93.853). The opportunity was created on January 22, 2024, and the listed original closing date is June 25, 2026. While the excerpt does not provide an award ceiling or the number of expected awards, the intent is clear: support projects that can credibly demonstrate that a biomarker measurement method meets a high analytical bar, producing data that are reproducible and accurate enough to support subsequent regulatory discussions and broader adoption in neurological or neuromuscular disease research and development.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2024-01-22.
• Applicants must submit their applications by 2026-06-25. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 24 098

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