Development of a JBS HI-LO Urine DNA Kit

JBS HI-LO 尿液 DNA 试剂盒的开发

• 批准号: 9792388
• 负责人: Zhili Wang
• 金额: $ 90.95万
• 依托单位: JBS SCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-24 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9792388
• 关键词: Address; Blinded; Blood; CTNNB1 gene; Cancer Diagnostics; Cells; Clinic; Clinical; Collection; DNA; DNA sequencing; Data; Data Analyses; Data Reporting; Detection; Development; Diagnostic; Ensure; Environment; Feasibility Studies; Freezing; Genetic screening method; Genome; Genomics; Goals; Head; Hour; Human; Immunotherapy; Methods; Molecular Weight; Monitor; Mutation; Nucleic Acids; Nucleotides; Patients; Performance; Peripheral Blood Mononuclear Cell; Phase; Plasma; Preparation; Primary carcinoma of the liver cells; Procedures; Protocols documentation; Public Health; Recovery; Research; Sampling; Science; Source; Specimen; Spottings; Swab; TP53 gene; Technology; Temperature; Testing; Time; Transplantation; Transportation; Tumor Tissue; Urine; Variant; Whole Blood; base; blind; cell free DNA; commercialization; cost; cost effective; falls; genome analysis; genome sequencing; genomic data; human data; improved; insertion/deletion mutation; medical schools; minimally invasive; next generation sequencing; phase 1 study; phase 2 study; precision medicine; prenatal; prototype; sample collection; tumor; user-friendly; validation studies; whole genome

Development of a JBS Hi-Lo urine DNA kit There is a critical need for sensitive and cost-effective technologies that can obtain high quality and comprehensive genomic data from easy-to-collect and handle human specimens. Currently, fresh or frozen whole blood is the most commonly used source to obtain high quality and comprehensive genomic data. However, the use of whole blood requires stringent collection, handling, and storage conditions. Alternatively, other minimally-invasive specimen types (such as dried blood spot, buccal swab, etc.) provide limited and low quality starting material for genomic analysis. JBS Science Inc. proposes a method utilizing urine as the source for both germline and cell-free circulating DNA based on our successfully accomplished phase I feasibility study. The objective of this project is to develop the JBS Hi-Lo urine DNA kit, which will provide a complete end-to-end solution addressing all steps including sample collection, storage, transportation and nucleic acid extraction. This kit will generate DNA suitable for whole genomic sequencing applications for both clinic and research purposes, such as (but not limited to) cancer diagnostics, tumor mutational load for predicting benefit from immunotherapy, precision medicine, prenatal diagnostics, and transplant monitoring. In the Phase II of this study, we will develop a sensitive and cost-effective market-ready JBS Hi-Lo urine DNA kit that is user-friendly with regard to room temperature storage and transportation. The kit will be validated in a blinded study that evaluates the recovery of HCC ctDNA markers obtained from urine and DNA from matched blood, from patients with HCC and will compare their ability to provide high quality DNA for obtaining comprehensive genomic information.

JBS Hi-Lo尿DNA检测试剂盒的研制 迫切需要敏感和成本效益高的技术，能够获得高质量和 从易于收集和处理的人类标本中获得全面的基因组数据。目前，新鲜或 冷冻全血是最常用的来源，以获得高质量和全面的 基因组数据然而，全血的使用需要严格的收集、处理和储存 条件或者，也可以使用其他微创标本类型（例如干血斑、颊粘膜）。 拭子等）为基因组分析提供有限且低质量的起始材料。JBS Science Inc. 提出了一种利用尿液作为生殖系和无细胞循环DNA来源的方法， 我们成功完成了第一阶段的可行性研究该项目的目标是开发 JBS Hi-Lo尿液DNA试剂盒，将提供完整的端到端解决方案，解决所有步骤 包括样本采集、储存、运输和核酸提取。这个工具包将产生 适用于临床和研究目的的全基因组测序应用的DNA，例如 作为（但不限于）癌症诊断，用于预测从以下方面获益的肿瘤突变负荷： 免疫治疗、精准医疗、产前诊断和移植监测。在第二阶段， 这项研究，我们将开发一个敏感和成本效益的市场准备JBS Hi-Lo尿液DNA试剂盒， 在室温储存和运输方面用户友好。该试剂盒将在 评价从尿液中获得的HCC ctDNA标记物和来自 匹配的血液，从HCC患者，并将比较他们的能力，提供高质量的DNA， 获得全面的基因组信息。