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

Active
Yes
Status
Posted
Published Date
October 21st, 2021
Close Date
September 13th, 2024
Award Ceiling
$250,000.00
Opportunity No.
PAR-22-049

Agency

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The National Institutes of Health (NIH) is offering a federal grant opportunity titled "Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)". This grant aims to support extramural research in investigating and mitigating challenges faced in clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies, or other biospecimens. The research funded under this grant will explore the preanalytical variability associated with the procurement and study of various biospecimens, such as small biopsies, blood, tissue swabs, tissue secretions, and bodily fluids. The goal is to improve the understanding of how different preanalytical conditions affect biomarkers and to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices. The grant does not require cost sharing or matching and falls under the category of health. The deadline for application submission is September 13, 2024. For more information and to apply, visit the following link: Integrating Biospecimen Science Approaches into Clinical Assay Development Grant.

Description

This Funding Opportunity Announcement (FOA) will 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 FOA. Extramural research funded under this FOA 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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