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

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-25-055

Response due Jun 22, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications under Program Announcement PAR-25-055 for clinical validation of candidate biomarkers for neurological or neuromuscular disorders. The U01 cooperative agreement mechanism supports collaborative research between applicants and NIH staff. Clinical trials are optional under this announcement. The opportunity is open for an extended period from October 2024 through June 2026, suggesting multiple submission cycles.

What they want

Technical requirements

Applicants must propose clinical validation studies of a candidate biomarker
Research must relate to neurological or neuromuscular disorders
Clinical trial component is optional but permitted under this announcement
U01 cooperative agreement mechanism applies, requiring active NIH involvement

How they evaluate

Submission: Grants.gov federal grants portal (electronic submission)

Risks & flags

Extended open window (nearly 2 years) suggests rolling submission cycles — individual due dates per cycle not extractable from this synopsis alone
Minimal detail provided in the synopsis; full funding opportunity announcement (FOA) text not included, limiting full scope assessment

Market context

inferred from NAICS

Professional, Scientific & Technical Services

NAICS 541711

US market size: $2.0T
Typical award: $25K – $50M

Typical buyers

All federal civilianDoDStates

Commonly required

8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Clinical Validation of a Candidate Biomark…

Due Jun 22

Onboard ↗