Commercialization of cavitation-enhancing nanodroplets for DNA sample fragmentation in NGS applications

用于 NGS 应用中 DNA 样品碎片化的空化增强纳米液滴的商业化

基本信息

批准号：
10081304
负责人：
Sandeep Kasoji
金额：
$ 84.47万
依托单位：
TRIANGLE BIOTECHNOLOGY, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-05 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10081304
关键词：
Acoustics Address Base Pairing Bathing Biological Biotechnology Cell Line DNA DNA Fragmentation DNA Sequencing Facility Development Digestion Due Process Enhancement Technology Equipment Exclusion Exposure to Face Fluorocarbons Freezing Generations Genes Genetic Genomic DNA Genomics Gold Head Health Technology Human Genome Project Individual Industry Industry Standard Interview Large-Scale Sequencing Legal patent Length Libraries Methods Modification Output Pain Performance Phase Positioning Attribute Pregnancy Tests Preparation Price Production Protocols documentation Public Health Quality Control Reagent Reproducibility Risk Sales Sampling Ships Signal Transduction Single Nucleotide Polymorphism Small Business Innovation Research Grant Sonication Standardization Technology Testing Time Transistors Tube Ultrasonics Validation Work commercialization cost design exome gene therapy genetic analysis genetic testing human DNA improved innovation insertion/deletion mutation instrument nanoDroplet next generation sequencing novel personalized diagnostics precision medicine product development prototype research and development scale up success validation studies whole genome

项目摘要

PROJECT SUMMARY The completion of the Human Genome Project has established NGS as the gold standard technology for personalized/precision medicine and diagnostics. Genetic testing kits are now as readily available as pregnancy test kits, and advances in genetic analysis, gene therapy, and genetic modification in the 21st century promise to parallel the development of transistors and integrated circuits in the 20th century. The challenge is that technology for preparing biological samples for sequencing has not maintained a similar rapid advancement to gene sequencing. Fragmentation of DNA randomly without bias is an essential, but difficult step in the preparation of genomic DNA for NGS applications. A narrow range of DNA fragment lengths is required for sequencing, and inefficient or inconsistent fragmentation will result in incomplete or excluded reads, corrupting the sequencing. Sonication, which fragments DNA through cavitation, is the gold standard for DNA fragmentation. However, our customer discover interviews have reinforced that this is a significant pain point in their sample preparation process due to its low throughput and inconsistency, particularly for industry developing large-scale sequencing efforts. We have invented a novel nanodroplet reagent that enhances cavitation from an acoustic sonicator, and greatly improves consistency and reduces time and acoustic power requirements for DNA fragmentation. Triangle Biotechnology has licensed the patents describing this cavitation enhancing technology. We have achieved milestones proposed in Phase I, demonstrating product and technical feasibility. With this SBIR Phase II, we will perform key R&D tasks, product development, and validation studies to prepare for commercialization. Success of this project will enable a novel commercial solution for addressing market pain points: substantially improving throughput and consistency of DNA fragmentation for NGS sample preparation while reducing cost.

项目概要人类基因组计划的完成确立了NGS作为黄金标准技术个性化/精准医疗和诊断。基因检测试剂盒现在像怀孕一样容易获得检测试剂盒以及 21 世纪基因分析、基因治疗和基因改造方面的进步有望 20世纪晶体管和集成电路的发展并行。挑战在于技术制备用于测序的生物样品尚未保持与基因类似的快速进步测序。 DNA 的无偏性随机片段化是制备 DNA 过程中必不可少但困难的一步。用于 NGS 应用的基因组 DNA。测序所需的 DNA 片段长度范围较窄，并且低效或不一致的片段化将导致读取不完整或被排除，从而破坏测序。超声处理通过空化作用使 DNA 片段化，是 DNA 片段化的黄金标准。然而，我们的客户发现访谈强化了这是他们样本中的一个重要痛点制备过程由于其低通量和不一致性，特别是对于开发大规模的工业排序工作。我们发明了一种新型纳米液滴试剂，可以增强声波超声发生器的空化作用，并且极大地提高了 DNA 碎片的一致性并减少了时间和声功率要求。三角生物技术公司已获得描述这种空化增强技术的专利授权。我们已经实现了第一阶段提出的里程碑，证明了产品和技术的可行性。和在这个 SBIR 第二阶段，我们将执行关键的研发任务、产品开发和验证研究，为商业化。该项目的成功将为解决市场问题提供一种新颖的商业解决方案痛点：大幅提升NGS样本DNA片段化的通量和一致性准备的同时降低成本。