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

Description

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.

Official source

Eligible beneficiaries

• Native American tribal organizations (other than Federally recognized tribal governments)
• Private institutions of higher education
• City or township governments
• Special district governments
• Public housing authorities/Indian housing authorities
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• State governments
• Independent school districts
• Small businesses
• Nonprofits having 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 governments (Federally recognized)
• County governments
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education