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

项目总结 人类基因组计划的完成使NGS成为 个性化/精准医疗和诊断。基因检测试剂盒现在就像怀孕一样容易获得 检测试剂盒，以及21世纪遗传分析、基因治疗和基因改造的进展有望 与20世纪晶体管和集成电路的发展相提并论。挑战在于，技术 为测序准备生物样本并没有保持与基因类似的快速进步 测序。DNA无偏随机碎裂是制备DNA的基本步骤，但也是困难的一步 用于NGS应用的基因组DNA。测序需要很小范围的DNA片段长度，以及 低效或不一致的碎片将导致读取不完整或被排除，从而破坏排序。 超声法是通过空化来粉碎DNA，是DNA碎裂的黄金标准。 然而，我们的客户发现访谈强调，这是他们样本中的一个重要痛点 由于其制备量低且不一致，尤其适用于工业规模化开发 测序工作。 我们已经发明了一种新的纳米液滴试剂，它可以增强声学声化器的空化，并且 大大提高了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经授权了描述这种空化增强技术的专利。 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。使用 在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。该项目的成功将为市场提供一种新的商业解决方案 痛点：显著提高NGS样本的DNA片段吞吐量和一致性 在降低成本的同时做好准备。

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.