Development of a JBS HI-LO Urine DNA Kit

JBS Hi-Lo尿DNA试剂盒的研制 迫切需要敏感和具有成本效益的技术，以获得高质量和 从易于收集和处理的人类样本中获得全面的基因组数据。目前，Fresh或 冷冻全血是获得优质、全面的血液最常用的来源 基因组数据。然而，使用全血需要严格的采集、处理和储存 条件。或者，其他微创标本类型(如干血斑、口腔 拭子等)为基因组分析提供有限和低质量的起始材料。JBS科学公司 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 关于我们成功完成的第一阶段可行性研究。这个项目的目标是开发 JBS Hi-Lo尿液DNA试剂盒，它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。该工具包将生成 适合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，肿瘤突变负荷预测受益于 免疫治疗、精确医学、产前诊断和移植监测。在第二阶段 在这项研究中，我们将开发一种灵敏且经济高效的JBS Hi-Lo尿DNA试剂盒，该试剂盒是 在室温储存和运输方面用户友好。该试剂盒将在 一项盲法研究，评估从尿液和DNA中获得的肝细胞癌ctDNA标记物的回收率 来自肝癌患者的匹配血液，并将比较他们提供高质量DNA的能力 获取全面的基因组信息。

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.