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Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-24-304
Response due Oct 14, 2026 · 00:00 UTC

Summary

This NIH funding opportunity (PAR-24-304) invites revision applications to existing R01 research grants for the purpose of validating biomarker assays that were developed through NIH-supported research. Clinical trials are explicitly not allowed under this mechanism. The opportunity is open on a rolling basis from October 2024 through October 2026, allowing current NIH R01 grantees to request supplemental funding to advance biomarker assay validation work.

What they want

Applicants must submit revision (supplement) applications to active NIH R01 grants to conduct validation studies of biomarker assays previously developed under NIH-supported research. Work must be limited to assay validation activities and must not involve clinical trials. Proposals are expected to demonstrate scientific rigor in the validation methodology for the relevant biomarkers.
Technical requirements
  • Applicant must hold an active NIH R01 grant
  • Biomarker assay must have been developed through NIH-supported research
  • Clinical trials are not allowed under this mechanism
  • Submission must be in the form of a revision (supplement) application

How they evaluate

Submission: Grants.gov federal grants portal submission

Risks & flags

  • Restricted to existing NIH R01 grantees only — effectively limits competition to a narrow, pre-qualified pool of applicants
  • Revision/supplement mechanism means only current grant holders are eligible, excluding new entrants entirely

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.

Revision Applications for Validation of Bi…
Due Oct 14
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