Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for research institutions and academic medical centers developing clinical assays using biospecimen science approaches. Eligible applicants include NIH-supported research organizations, universities, and medical schools. Non-profit organizations and government agencies may also qualify. The grant supports early-stage research aimed at integrating biospecimen collection, handling, and analysis into clinical assay platforms. Clinical trials are not allowed under this funding mechanism. Projects must demonstrate innovation in biospecimen-based diagnostic or prognostic development. International organizations are generally ineligible unless they have U.S.-based research components.
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Program description
Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies”, or other biospecimens as described in this NOFO. Extramural research funded under this NOFO may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for “liquid biopsies”, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) form
- Project Narrative (detailed research plan)
- Specific Aims page
- Preliminary Data section
- Budget and Budget Justification
- Biosketches (key personnel)
- Letters of Support or Collaboration Agreements
- Institutional Animal Care and Use Committee (IACUC) approval if applicable
- Institutional Biosafety Committee (IBC) approval if applicable
- Data Management and Sharing Plan
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.393 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$213,206,023
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$56,551,552
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$48,640,472
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$47,009,863
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$42,878,192
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$37,448,862
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$29,324,004
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$26,395,336
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$24,427,436
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$23,149,727
Top States by Funding
- MA 10 awards $374.4M
- CA 10 awards $260.1M
- MN 4 awards $106.9M
- NY 7 awards $99.9M
- TN 7 awards $97.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.393). How funding has trended year over year.
| 2024 | $754,945,159 | |
| 2025 | $834,514,512 | |
| 2026 est. | $520,096,276 |
FAQ
Who is eligible to apply for this grant?
Research institutions, universities, medical schools, and non-profit research organizations with NIH experience. Government agencies are typically eligible too.
What activities are supported?
Development of clinical assays using biospecimen science. Methods improvement, validation studies, and research tool development are included. Clinical trials are explicitly not allowed.
When is the deadline?
The deadline is September 10, 2027. Applications typically open 6-8 weeks before the deadline.
How much funding should I expect?
U01 awards vary widely. Total project costs typically range from $100K to $500K annually, but check the Funding Opportunity Announcement for exact limits.
How competitive is this mechanism?
U01 grants are moderately to highly competitive. Success requires strong preliminary data and a clear innovation in biospecimen integration into clinical workflow.
💡 Tips for applicants
- Lead with your biospecimen science innovation. Show how it improves clinical assay reliability or efficiency.
- Include preliminary data demonstrating feasibility of your approach and proof-of-concept validation.
- Clarify exactly why clinical trial data collection is different from testing an assay in a clinical setting.
- Budget for biospecimen procurement, validation, and quality control. These costs are often underestimated.
- Partner with a clinical laboratory or biorepository to strengthen credibility and resource access.
⚠️ Common mistakes
Proposing a project with human subjects data collection that resembles a clinical trial. Underestimating biospecimen quality control and validation timelines. Submitting without preliminary data showing assay feasibility in relevant sample types.
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