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Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-25-074
Response due Oct 14, 2026 · 00:00 UTC

Summary

This NIH funding opportunity (PAR-25-074) supports the validation of high-quality biomarker assays intended for use in clinical cancer studies. It uses the UH2/UH3 cooperative agreement mechanism, which typically involves a milestone-driven phased approach — UH2 for development/feasibility and UH3 for implementation. Clinical trials are explicitly not allowed under this announcement. The opportunity is open on a rolling basis from October 2024 through October 2026.

What they want

Applicants must conduct assay validation activities for high-quality biomarkers intended for use in clinical cancer studies. The UH2 phase is expected to focus on assay development and validation feasibility, while the UH3 phase transitions to broader implementation. Clinical trials are explicitly excluded from allowable activities under this Notice of Funding Opportunity (NOFO).
Technical requirements
  • Assay validation for cancer biomarkers intended for clinical studies
  • Must follow UH2/UH3 phased cooperative agreement structure
  • Clinical trials are not allowed under this funding opportunity
  • Milestone-driven approach expected across UH2 and UH3 phases

How they evaluate

Submission: Grants.gov electronic submission portal

Risks & flags

  • Rolling two-year submission window with no specific review cycles mentioned — may favor established NIH-connected research teams
  • UH2/UH3 mechanism is a cooperative agreement with significant NIH involvement, potentially limiting independent applicants

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.

Assay Validation of High Quality Markers f…
Due Oct 14
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