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

The Integrating Biospecimen Science Approaches into Clinical Assay Development grant (U01 Clinical Trial Not Allowed) is a Funding Opportunity Announcement (FOA) that aims to provide support for external research. The research should focus on examining and mitigating the challenges faced in developing clinical assays and the ensuing analytical validation due to preanalytical variations in tumor tissue biopsies and blood biospecimens used as liquid biopsies, among other biospecimens.

Under this FOA, the funded research may look into the preanalytical variability pertaining to the collection and study of small biopsies (including core biopsies, small excision samples), blood used for liquid biopsies, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, and bodily fluids like sweat, urine, cerebrospinal fluid (CSF), breast milk and saliva.

In the course of their investigations, the researchers are encouraged to devise their own experiments to understand how different conditions related to biospecimen collection can affect emerging and clinically significant biomarkers. These biomarkers can be quantified using a variety of testing platforms.

The results from the research funded by this program would further our understanding of how analytical quantification of important biomarkers is influenced by variations in biospecimen collection, processing, and storage procedures.

Ultimately, this program aims to speed up the development of biomarker clinical assays through providing standardized and evidence-based guidelines for how biopsies should be handled.