Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional) | PAR 24 096

Opportunity Information: Apply for PAR 24 096

The NIH funding opportunity PAR-24-096, titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)," supports projects that move a strong biomarker candidate from promising evidence to real clinical credibility in the patient population where it is intended to be used. The central aim is clinical validation: generating rigorous data that show how well a biomarker measurement performs in practice, specifically by establishing positive predictive value and negative predictive value in a defined clinical context of use, in a way that aligns with FDA expectations for biomarker evaluation. In other words, the program is designed to answer the practical questions clinicians, researchers, and regulators will ask: when the biomarker result is positive, how often is that truly associated with the condition or outcome of interest, and when it is negative, how often does it reliably rule it out?

This announcement is not meant for early discovery work. It assumes key groundwork is already done before applying. First, the biomarker itself must already be identified as a candidate with strong supporting evidence. Second, the measurement method or detection technology must already exist and be analytically validated, meaning the assay or measurement approach has already been shown to work technically (for example, accuracy, precision, reliability, and other analytical performance features have been characterized). Third, there must already be a clear research and/or clinical need, along with a plausible and well-defined context of use, such as supporting diagnosis, prognosis, patient stratification, monitoring disease progression, or assessing treatment response in a specified neurological or neuromuscular disorder setting. The grant is therefore aimed at bridging the gap between analytical readiness and clinical readiness, focusing on validation in the real-world clinical population where the biomarker would ultimately matter.

The funding mechanism is a Cooperative Agreement (U44), which typically means the NIH expects an active partnership role compared with a standard research project grant. This often involves closer coordination with NIH program staff and milestones-oriented project management, particularly appropriate for translational efforts like biomarker validation where study design rigor, recruitment feasibility, and performance targets are critical. The opportunity is labeled "Clinical Trial Optional," indicating that applicants may propose studies that include clinical trial elements if appropriate, but a clinical trial is not automatically required for every project; the key requirement is that the work directly supports clinical validation of the biomarker in the relevant population.

Eligible applicants span a broad range of organization types, reflecting the program's translational and implementation-oriented nature. Eligible entities include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations (other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status (excluding institutions of higher education where noted); for-profit organizations (including those other than small businesses); and small businesses. The announcement also explicitly notes additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it draws a clear boundary around non-U.S. involvement: non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, which can enable certain internationally located activities or collaborations when they are justified and structured within NIH policy.

Administratively, the opportunity is offered by the National Institutes of Health and is categorized under discretionary funding for health (CFDA 93.853). The original closing date is listed as June 22, 2026. The award ceiling and expected number of awards are not specified in the provided listing, which often means applicants should review the full announcement for budget guidance, project period limits, milestone expectations, and any institute- or program-specific caps or preferences.

Overall, this program is best understood as a translational push to produce clinically meaningful evidence for a biomarker that is already technically mature and biologically plausible. The emphasis is on careful validation design in the intended patient population, producing predictive value data that can support next-step adoption, qualification discussions, or regulatory-aligned decision-making, rather than on discovering new biomarkers or inventing new assay platforms from scratch.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical 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 2026-06-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 24 096

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