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Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)

US National Institutes of Health (NIH) grant open #PAR-25-325
Response due Sep 10, 2027 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting research applications under Program Announcement PAR-25-325 to integrate biospecimen science approaches into clinical assay development. This is a U01 cooperative research grant mechanism, explicitly excluding clinical trials. The opportunity is open for a multi-year window from December 2024 through September 2027, indicating a rolling or multiple-cycle submission structure. The focus is on advancing the scientific rigor and translational utility of clinical assays by incorporating biospecimen science methodologies.

What they want

Applicants must propose research that integrates biospecimen science approaches into the development of clinical assays. The grant mechanism is U01 (cooperative agreement), and clinical trials are explicitly not allowed under this announcement. Research is expected to advance methodologies at the intersection of biospecimen handling/processing and clinical diagnostic or laboratory assay development.
Technical requirements
  • Clinical trials not allowed (U01 mechanism only)
  • Must integrate biospecimen science approaches
  • Must focus on clinical assay development
  • Cooperative agreement (U01) grant mechanism applies

How they evaluate

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

Risks & flags

  • Ultra-long open window (nearly 3 years) suggests rolling submission cycles — specific cycle deadlines not provided in source text
  • Clinical trial exclusion is a hard eligibility constraint that may narrow applicant pool significantly
  • No dollar value or award ceiling stated — budget expectations unclear from available text

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
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.

Integrating Biospecimen Science Approaches…
Due Sep 10
Onboard ↗