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

PROJECT SUMMARYThe 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 Randamp;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.RELEVANCE TO PUBLIC HEALTHTechnology for preparing biological samples for next generation sequencing (NGS) faces several bottlenecks which have become significant pain points. Our innovative cavitation enhancing nanodroplet reagent overcomes throughput and consistency bottlenecks in sample preparation for (NGS) technologies. With this SBIR Phase II, we will perform key research, development, and validation studies required for commercialization.