CAPTIS DIAGNOSTICS - SBIR CONCEPT AWARD - DEVELOPMENT OF NON-INVASIVE ASSAY FOR MOLECULAR CHARACTERIZATION OF PEDIATRIC LOW-GRADE GLIOMA

CAPTIS DIAGNOSTICS - SBIR 概念奖 - 开发儿科低级别胶质瘤分子表征的非侵入性检测方法

• 批准号: 10585857
• 负责人: HONGZHANG HE
• 金额: $ 35.46万
• 依托单位: CAPTIS DIAGNOSTICS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-20 至 2023-01-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10585857
• 关键词: Award; Biological Assay; Biopsy; Childhood; Childhood Central Nervous System Neoplasm; Clinical; Development; Diagnosis; Diagnostic; Face; Glioma; Goals; Gold; Heterogeneity; Methods; Molecular; Monitor; Mutation; Neuraxis; Nucleic Acids; Plasma; Sampling; Small Business Innovation Research Grant; Technology; Tissues; Validation; base; clinically significant; diagnostic tool; extracellular vesicles; nanomaterials; tumor

Current molecular characterization of pediatric low-grade glioma (pLGG) face significant challenges: (1) the gold standard tissue biopsy is invasive and often unfit for pLGG diagnosis and repetitive monitoring; (2) tissue biopsy is unable to capture the heterogeneity present within the entire tumor. The long-term goal of this proposal is to reduce the burden of pediatric central nervous system (CNS) tumors through developing paradigm shifting diagnostic tools. This proposal proposes to overcome these challenges by developing the first non-invasive extracellular vesicle (EV)-based assay for pLGG diagnosis with two specific aims: (1) developing nanomaterial-based technology for selective isolation of CNS-EV; (2) validate the nanomaterial-based technology in non-invasive molecular characterization of pLGG. Two-pronged approach will be used to achieve the milestones: (1) nanomaterial-based technology will be optimized to enrich CNS-EVs from plasma; (2) detecting clinically significant EV nucleic acid mutation from nanomaterial-isolated CNS-EVs from plasma of pLGG. This SBIR will result in (1) a nanomaterial-based kit for CNS-EV isolation; (2) proof-of-concept validation of non-invasive nanomaterial-based technology with pLGG plasma, which is ready for large clinical validation. Compared with the gold standard method invasive tissue biopsy, the proposed non-invasive technology is expected to provide a paradigm shift in the treatment and management of pLGG.

目前儿童低级别胶质瘤(PLGG)的分子特征面临着重大挑战：(1)金标准组织活检是侵入性的，通常不适合pLGG诊断和重复监测；(2)组织活检无法捕捉整个肿瘤内存在的异质性。这项建议的长期目标是通过开发范式转换诊断工具来减轻儿科中枢神经系统(CNS)肿瘤的负担。为了克服这些挑战，本提案建议开发第一个基于非侵入性细胞外小泡(EV)的pLGG诊断方法，其具体目的有两个：(1)开发基于纳米材料的技术用于选择性分离CNS-EV；(2)验证基于纳米材料的技术在pLGG非侵入性分子表征中的有效性。为了实现这些里程碑，将使用双管齐下的方法：(1)优化基于纳米材料的技术，以从血浆中浓缩CNS-EVS；(2)从pLGG血浆中检测具有临床意义的EV核酸突变。这项SBIR将产生(1)用于CNS-EV分离的基于纳米材料的试剂盒；(2)使用pLGG血浆对基于非侵入性纳米材料的技术进行概念验证，该技术已准备好用于大规模临床验证。与金标准方法有创组织活检相比，提出的非侵入性技术有望为pLGG的治疗和管理提供一种范式转变。