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

该项目的目标是提供一种完全集成的、CLIA认证的检测方法，利用无细胞核酸(CfNA)为胶质母细胞瘤提供诊断和疾病监测能力。我们将使用一种新的专利浓缩技术(NeXosome)结合核酸分离方法从血液中分离cfNA，作为评估胶质母细胞瘤标志物IDH1突变状态的手段。NeXosome平台将大小排除层析与专有缓冲液结合在一起，优先从病变组织中浓缩cfNA，从而与当前技术相比，cfNA具有更大的丰度和异质性。 这一第一阶段合同的具体任务是：1)建立一种全面浓缩cfna的可靠方法。2)证明突变株IDH1与野生型IDH1在血浆中可以区分开来。3)分析验证muIDH1cfNA法。4)制定向FDA提交muIDH1检测的管理计划。 这份SBIR合同将使完全集成和强大的cfNA浓缩和分析系统的开发成为可能，以支持cfNA分子技术在胶质母细胞瘤的诊断和治疗中的应用。

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.