IGF::OT::IGF R&D- MEDICAL: BIOMEDICAL (BASIC RESEARCH)

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The objective of this project is to deliver a fully integrated, CLIA-certified assay that provides diagnostic and disease monitoring capabiliteis in gliablastoma using cell-free nucleic acids (cfNA). We will use a novel, patented enrichment technique (NeXosome) coupled with nucleic acid isolation methods to isolate cfNA from blood as means to evaluate the glioblastoma marker IDH1 mutation status. The NeXosome platform couples size exclusion chromatography with proprietary buffers to preferential enrich cfNA from diseased tissue allowing for greater abundance and heterogeneity of cfNA compared to current techniques. The specific tasks for this Phase I contract are to: 1) Establish a robust method for comprehensive enrichment of cfNA. 2) Demonstrate that mutant IDH1 can be distinguished from wild type IDH1 in plasma. 3) Analytically validate mutIDH1 cfNA assay. 4) Develop a regulatory plan for the submission of mutIDH1 assay to the FDA. This SBIR contract will enable development of a fully integrated and robust cfNA enrichment and analysis system to support the use of cfNA molecular techniques in the diagnosis and management of glioblastoma.