Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional) | PAR 24 095

Opportunity Information: Apply for PAR 24 095

This NIH funding opportunity (PAR-24-095) supports projects that are ready to move a promising neurological or neuromuscular biomarker from the "we think this could work" stage into a rigorously validated measurement method that can be relied on across labs and studies. It is a reissue of PAR-21-056 and is focused on analytical validation, meaning the main emphasis is not discovering new biomarkers, but proving that an existing candidate biomarker can be measured accurately, reproducibly, and consistently using a well-defined detection method. The program is aimed at the kind of validation work that aligns with FDA expectations for assay performance, so the output should be the sort of evidence package that shows the method is technically sound and dependable under real-world conditions.

The core purpose is to evaluate and lock down the analytical performance of a biomarker measurement method. That includes studying the detection approach itself, documenting performance characteristics (for example, accuracy, precision, sensitivity, specificity, limits of detection/quantification, linearity, dynamic range, robustness, and sources of variability), and determining the optimal conditions needed to generate reproducible results. In practical terms, applicants are expected to define and test the full measurement workflow, which can include specimen handling and processing, reagent and instrument settings, calibration strategies, quality control materials, batch effects, operator effects, and inter-site reproducibility when relevant. The program is essentially designed to fund the method validation steps that are often necessary before a biomarker can be used confidently in clinical research, patient stratification, or as part of a pathway toward regulatory acceptance for a defined context of use.

This announcement assumes three key prerequisites are already in place before applying. First, the candidate biomarker has already been identified, so the application should not be framed as a discovery effort. Second, a detection method technology has already been developed, meaning there is an assay, platform, or measurement approach that exists and can be subjected to formal validation rather than invented from scratch. Third, the clinical or research need and a plausible context of use have been identified, so applicants should be able to explain what the biomarker is intended to do (for example, aid diagnosis, monitor disease progression, measure target engagement, predict response, or support patient selection) and in what setting it is expected to matter. While the funding supports analytical validation rather than full clinical validation, the context of use matters because it guides what performance thresholds and operating conditions are actually required.

The award mechanism is a U01 cooperative agreement, which generally means NIH expects substantial programmatic involvement compared with a standard grant. In cooperative agreements, investigators still lead the science, but the NIH scientific staff often play an active role in shaping milestones, monitoring progress, coordinating across related efforts, and ensuring that the validation work stays aligned with program goals and community standards. The opportunity is labeled "Clinical Trial Optional," which signals that a clinical trial is not required but may be proposed if it is necessary to accomplish the analytical validation aims. In many biomarker validation projects, clinical specimens and clinical cohorts may be involved without necessarily constituting a clinical trial; applicants typically need to be clear about whether their work meets NIH definitions of a clinical trial and justify the design accordingly.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and U.S. territories or possessions, among others.

Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement. In practice, that typically means a U.S. applicant organization may include certain foreign collaborations or activities as a foreign component when scientifically justified and allowed under NIH policy, but the applicant institution itself must be domestic.

From a logistics standpoint, the sponsoring agency is the National Institutes of Health, the opportunity category is discretionary, the activity category is health, and the CFDA (now commonly referenced through Assistance Listings) number provided is 93.853. The original closing date listed is 2026-06-22. The source information provided does not specify an award ceiling or the expected number of awards, so applicants would generally need to consult the full FOA text and any related NIH institute-specific guidance for budget expectations, project period norms, and program priorities.

Overall, the opportunity is best suited for teams who already have a high-confidence biomarker candidate and a working assay or measurement platform, and who now need resources to do the careful, sometimes unglamorous but essential work of proving the assay performs reliably. The deliverable NIH is effectively pushing toward is an analytically validated biomarker measurement method with documented performance and standardized operating conditions, suitable for broader adoption in neurological or neuromuscular research and positioned for future steps toward clinical implementation or regulatory-grade use.

• 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(U01 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 24 095

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