Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
Last verified by NonDilute: 2026-06-08. Official notice and agency instructions control.
If you research how biospecimen handling affects clinical diagnostics, this NCI grant funds the experimental work to standardize procedures and accelerate assay validation.
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What this is
This U01 grant supports research into preanalytical variability in tissue biopsies, liquid biopsies, and other biospecimens used in clinical assays. Funded teams will design experiments examining how different collection and storage conditions affect biomarker quantification across various testing platforms. Results aim to establish evidence-based standards for biospecimen handling to reduce variability and accelerate clinical assay development and analytical validation. Clinical trials are explicitly not allowed under this mechanism.
Who can apply
Nonprofits (with or without 501(c)(3) status), small businesses, for-profit companies, universities, government entities, and tribal organizations are eligible. Notably, the opportunity is open to a broad range of entity types including solo researchers and small teams, though applications must come through an eligible institutional entity. Geographic restriction: U.S.-based organizations only.
Eligible applicant types
- Independent school districts
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Public housing authorities/Indian housing authorities
- Native American tribal governments (Federally recognized)
- State governments
- City or township governments
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Small businesses
- Special district governments
- Private institutions of higher education
- County governments
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Public and State controlled institutions of higher education
- For profit organizations other than small businesses
- Native American tribal organizations (other than Federally recognized tribal governments)
Full description — from the agency
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.
Topics: biospecimen science · clinical assay development · biomarker validation · preanalytical variability · liquid biopsy · tissue biopsy standardization · analytical validation
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