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

National Institutes of HealthAmount not specifiedDue Sep 10, 2027

Researchers Schools & universities Government / tribal Narrow eligibility

Deadline: Sep 10, 2027
Posted: Dec 13, 2024
Award amount: Amount not specified
Focus areas: Education Health

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In plain English

This NIH (NCI, U01) program funds research on how preanalytical variability in handling tumor tissue, blood, and other biospecimens affects clinically relevant biomarkers, to support standardization of biopsy handling and clinical assay development. Eligible applicants are research organizations including universities, colleges, government and tribal entities, and faith- or community-based organizations; it targets established research teams, not individuals or general nonprofits. Award amounts are not specified. Confirm program-specific eligibility in the full announcement.

AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.

Who can apply

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

About this grant

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.

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