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

US · MD · Bethesda National Institutes of Health (NIH) grant open #PAR-25-075

Response due Oct 14, 2026 · 00:00 UTC

Summary

The National Institutes of Health (NIH) is soliciting applications under PAR-25-075 for the validation of assays targeting high-quality biomarkers intended for use in clinical studies related to cancer. The mechanism is a UH3 cooperative agreement, and clinical trials are explicitly not allowed under this opportunity. The program aims to advance cancer research by ensuring robust, validated assay methodologies suitable for clinical application. The opportunity was posted in October 2024 and remains open through October 2026.

What they want

Applicants must conduct assay validation activities for high-quality biomarkers (molecular, protein, imaging, or other markers) to support future clinical studies in cancer. Work excludes clinical trials. Funded projects are expected to demonstrate analytical validity of proposed markers and assays, with the goal of producing clinically actionable, reproducible assay protocols suitable for broader cancer research use. The cooperative agreement mechanism (UH3) implies substantial NIH programmatic involvement during execution.

Deliverables

Validated assay protocols for high-quality cancer biomarkers
Demonstration of analytical validity and reproducibility of proposed assays
Progress reports consistent with NIH cooperative agreement requirements

Technical requirements

Clinical trials are explicitly not allowed under this funding mechanism
Assay validation must target high-quality markers relevant to cancer clinical studies
UH3 cooperative agreement mechanism — substantial NIH programmatic involvement required

How they evaluate

Scientific and technical merit of proposed assay validation approach
Relevance of selected markers to cancer clinical studies
Qualifications and experience of the research team
Adequacy of proposed facilities and resources

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

Risks & flags

Two-year open window (Oct 2024–Oct 2026) with rolling submissions may favor established NIH-funded research groups with pre-existing biomarker programs
UH3 cooperative agreement mechanism involves significant NIH co-direction, which may disadvantage applicants unfamiliar with NIH collaborative research norms

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.

Assay Validation of High Quality Markers f…

Due Oct 14

Onboard ↗