Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)
Can you apply?
This grant is for research institutions and biomedical organizations seeking to validate candidate biomarkers for neurological or neuromuscular disorders. Applicants must be U.S.-based institutions capable of conducting rigorous analytical and clinical validation studies. Eligible recipients include universities, medical centers, research institutes, and nonprofit research organizations with active NIH grants support infrastructure.
Funding supports the analytical and/or clinical validation phase of biomarker development. Activities include assay development, analytical performance testing, and clinical utility studies. Both observational studies and clinical trials are permissible under this mechanism.
This is a federally-funded research program requiring institutional research capacity. Applicants must demonstrate scientific expertise, adequate laboratory facilities, and subject recruitment capability. Multi-institutional collaborations are encouraged.
This grant is for research institutions and biomedical organizations seeking to validate candidate biomarkers for neurological or neuromuscular disorders. Applicants must be U.S.-based institutions capable of conducting rigorous analytical and clinical validation studies. Eligible recipients include universities, medical centers, research institutes, and nonprofit research organizations with active NIH grants support infrastructure.
Funding supports the analytical and/or clinical validation phase of biomarker development. Activities include assay development, analytical performance testing, and clinical utility studies. Both observational studies and clinical trials are permissible under this mechanism.
This is a federally-funded research program requiring institutional research capacity. Applicants must demonstrate scientific expertise, adequate laboratory facilities, and subject recruitment capability. Multi-institutional collaborations are encouraged.
Program description
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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for research institutions and biomedical organizations seeking to validate candidate biomarkers for neurological or neuromuscular disorders. Applicants must be U.S.-based institutions capable of conducting rigorous analytical and clinical validation studies. Eligible recipients include universities, medical centers, research institutes, and nonprofit research organizations with active NIH grants support infrastructure.
Funding supports the analytical and/or clinical validation phase of biomarker development. Activities include assay development, analytical performance testing, and clinical utility studies. Both observational studies and clinical trials are permissible under this mechanism.
This is a federally-funded research program requiring institutional research capacity. Applicants must demonstrate scientific expertise, adequate laboratory facilities, and subject recruitment capability. Multi-institutional collaborations are encouraged.
How to apply
Application links
Required documents
- SF-424 (R&R) Application Form
- Project Narrative (Research Strategy)
- Specific Aims (1 page)
- Preliminary Studies/Progress Report
- Research Design & Methods
- Budget & Budget Justification
- Biographical Sketches (Key Personnel)
- Letters of Commitment/Support
- IRB/IACUC Approval Documentation (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.853 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$82,511,281
-
$67,362,785
-
$62,646,087
-
$56,144,651
-
$45,268,737
-
$40,959,789
-
$35,655,349
-
$35,655,116
-
$35,335,145
-
$34,183,297
Top States by Funding
- MA 6 awards $186.5M
- CA 4 awards $129.9M
- OH 4 awards $112.5M
- FL 3 awards $100.3M
- MN 2 awards $99.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.853). How funding has trended year over year.
| 2024 | $2,362,835,459 | |
| 2025 | $2,345,500,401 |
FAQ
Who is eligible to apply for this grant?
Universities, medical centers, research institutes, and nonprofit organizations with research infrastructure can apply. Your institution must be U.S.-based with capability to conduct rigorous validation studies.
What is the deadline for applications?
The fixed deadline is June 22, 2026. Applications became available October 2, 2024. Plan to submit well before the deadline to avoid technical issues.
What activities does this grant fund?
Funding supports analytical validation of biomarkers and optional clinical trial phases. This includes assay development, performance testing, and clinical utility assessment for neurological/neuromuscular disorders.
How competitive is this grant?
NIH U01 mechanisms are moderately to highly competitive. Strong preliminary data, clear validation strategy, and experienced leadership significantly improve competitiveness.
What is the typical funding amount and project period?
This is a U01 mechanism, typically providing substantial multi-year support. Exact funding depends on your proposed budget and NIH review, but expect 3-5 year project periods.
💡 Tips for applicants
- Show strong preliminary data demonstrating biomarker promise. Include existing analytical or clinical evidence supporting your validation approach.
- Clearly distinguish analytical validation from clinical validation phases. Explain which activities your project emphasizes and why that sequence makes sense.
- Assemble a multidisciplinary team with biomarker science, statistics, and clinical disease expertise. Include patient perspectives if possible.
- Detail your subject recruitment and retention plan, especially for rare neurological disorders. Address feasibility upfront.
- Align your specific aims with standard biomarker validation frameworks. Reference published validation guidelines relevant to your biomarker type.
⚠️ Common mistakes
Weak preliminary data fails to establish biomarker promise. Reviewers reject applications lacking credible evidence the marker measures what you claim.
Unclear validation pathway confuses analytical and clinical phases. Applications lacking distinct, logical study designs for each phase appear unfocused.
Underestimating subject recruitment timelines is common for rare disorders. Realistic recruitment plans with documented feasibility improve fundability.
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