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

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

Program Details

National Institutes of Health is a federal agency that offers the Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional) grant program to support eligible programs and projects. This funding opportunity is available nationally and is administered by National Institutes of Health through Grants.gov. Organizations seeking funding for eligible programs and projects should review the details below and confirm their eligibility before preparing an application.

Eligibility

Eligible applicants include government agencies and municipalities, eligible organizations, for-profit businesses, and educational institutions. Organizations that meet the eligibility criteria are encouraged to apply and to review the full program guidelines before submission. Because eligibility rules and funding priorities can change between cycles, applicants should always confirm the current requirements with National Institutes of Health or on Grants.gov before investing time in an application.

Funding and Timeline

Applications are due by June 22, 2026. Applicants should allow sufficient time to gather required documentation, including organizational information, project descriptions, budgets, and supporting materials as specified in the program guidelines. Submitting a complete application well ahead of the deadline reduces the risk of disqualification on technical or administrative grounds.

Program Focus

This grant supports eligible programs and projects. This grant is associated with NAICS industry classifications: 541714, 621111, 621112, 622. Organizations operating in these sectors are encouraged to review eligibility. Funded projects are expected to demonstrate measurable outcomes aligned with the program's stated objectives. Grant recipients may be required to submit progress reports and final evaluations as a condition of the award, and to retain records for audit and compliance purposes.

How to Apply

Eligible organizations can apply through Grants.gov. Create a free organization profile on GrantRegister to see whether this grant matches your organization's NAICS code, entity type, location, and focus area, and to receive a weekly digest of every open grant you qualify for.

GrantRegister maintains a complete, authoritative registry of US federal, state, and foundation grant opportunities — matched automatically to your organization profile and delivered every Monday.

Eligibility

• Funded by NIH

Award details

Applications close on June 22, 2026.

Categories

Not categorized