Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
About
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.
The Integrating Biospecimen Science Approaches into Clinical Assay Development grant, offered by the National Cancer Institute (NCI), supports extramural research focused on solving critical challenges in clinical assay development. This grant is designed for researchers and institutions investigating preanalytical variability in biospecimens—including tumor tissue biopsies, blood-based liquid biopsies, tissue swabs, and bodily fluids—that can affect biomarker quantification and analytical validation. The program funds investigator-designed experiments exploring how different collection, processing, and storage procedures impact emerging and clinically relevant biomarkers across various testing platforms. Eligible applicants include HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, faith-based and community-based organizations, and eligible federal agencies. Researchers should apply if they aim to advance biomarker clinical assay development through evidence-based standardization of biopsy handling practices. By addressing preanalytical variability scientifically, funded projects will improve the reliability and clinical translation of biomarker assays. This opportunity is ideal for academic medical centers, research institutions, and organizations committed to improving cancer diagnostics and precision medicine.
Funding Facts
● Applications openDeadline
September 10, 2027
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Funding Range
Varies by cycle
Deadline
2027-09-10
Grant Type
federal
Application Cycle
Annual (Deadline: September 10, 2027)
Best For
Research institutions, HBCUs, minority-serving institutions, cancer research centers, and biospecimen science laboratories focused on clinical assay development
Eligibility
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 Govern
Frequently Asked Questions
Who is eligible for Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)?
Eligible applicants include Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based and community-based organizations, and eligible federal agencies. For a complete and current list of eligible entity types, applicants should consult the official Notice of Funding Opportunity on the NIH website.
How much funding does Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed) provide?
Specific funding amounts are not listed in the available information. Applicants should visit the official National Cancer Institute funding opportunity page for details on award ranges and budget guidance for this funding cycle.
How do I apply for Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)?
Applications are submitted through the NIH grants portal. The application deadline is September 10, 2027. Applicants should review the complete Notice of Funding Opportunity (NOFO) on the NIH/NCI website for detailed instructions, eligibility requirements, application components, and submission procedures. Early planning is recommended to meet the deadline.
What can Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed) funding be used for?
Funding supports extramural research investigating and mitigating preanalytical variability in biospecimen handling and clinical assay development. This includes investigator-designed experiments examining how biospecimen collection, processing, and storage procedures affect biomarker quantification. Research may address challenges with tumor tissue biopsies, liquid biopsies, tissue swabs, secretions, bodily fluids, and other biospecimens. The goal is to generate evidence for standardizing biopsy handling practices to expedite biomarker clinical assay development.
Last updated: July 5, 2026