Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional) | PAR 18 549

Opportunity Information: Apply for PAR 18 549

The grant opportunity titled "Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)" (Funding Opportunity Number PAR-18-549) is a National Institutes of Health (NIH) funding program designed to help small businesses carry out rigorous analytical validation of proposed biomarkers or biomarker-based endpoints relevant to neurological disease. It uses a cooperative agreement mechanism (U44), meaning the funded project is expected to involve a more active partnership with NIH program staff than a standard grant, with NIH likely providing input on milestones, project direction, and other scientific or operational aspects as the work progresses. The activity area is health-related research and development, and it is associated with CFDA number 93.853.

The central goal of this FOA is analytical validation, which is the step where a biomarker measurement method is tested to prove it performs reliably and consistently for its intended purpose. In practical terms, this is about demonstrating that the assay, device, imaging readout, digital measure, or other biomarker measurement has acceptable performance characteristics under defined conditions. The announcement emphasizes alignment with FDA guidelines, signaling that projects should be structured in a way that supports eventual regulatory use or supports biomarker acceptance in regulated drug or device development settings. Analytical validation typically focuses on attributes such as accuracy, precision, sensitivity, specificity, reproducibility, robustness, limits of detection/quantification (where applicable), stability, and handling of sources of variability like operators, instruments, sites, batches, and time. The intent is to move candidate biomarkers beyond early exploratory findings and into a state where the measurement itself is dependable enough to be used as an endpoint or decision-making tool in later-stage research, clinical development, or potentially clinical practice, depending on the proposed context of use.

Eligibility is centered on Small Business Concerns (SBCs), indicating that applicants must meet the small business requirements applicable to NIH small business programs. The funding notice also clarifies boundaries around foreign involvement: non-domestic (non-U.S.) components of U.S. organizations are not eligible to apply as applicants themselves, but "foreign components" (as defined by the NIH Grants Policy Statement) may be allowable within an otherwise eligible application, depending on the specific terms in the full announcement. In other words, the applicant organization must be an eligible U.S. small business, but certain parts of the work may be conducted abroad if NIH policies and the FOA permit it and if the arrangement is justified.

The opportunity is categorized as discretionary funding, and the posted original closing date is September 7, 2020, with a creation date of December 22, 2017. The provided source excerpt does not list an award ceiling or an expected number of awards, so applicants would normally need to consult the full funding announcement for budget structure, project period expectations, milestone requirements, and any institute-specific priorities. The "Clinical Trial Optional" label indicates that a clinical trial may be proposed if it is appropriate for the analytical validation goals, but it is not mandatory; many analytical validation efforts can be completed using clinical specimens, retrospective datasets, controlled laboratory studies, or multi-site reproducibility testing without initiating a traditional interventional clinical trial.

Overall, PAR-18-549 is aimed at helping small businesses generate the kind of method performance evidence that regulators, industry partners, and the broader scientific community typically require before a neurological biomarker measure can be trusted as a fit-for-purpose endpoint. It is less about discovering new biomarkers and more about proving that a specific candidate measurement can be executed reliably, with clearly characterized performance, so it can credibly support downstream clinical or translational decisions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analytical Validation of a Candidate Biomarker for Neurological Disease (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 2017-12-22.
• Applicants must submit their applications by 2020-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 18 549

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