SBIR Phase I: Highly Selective and Rapid Separation of RNA to Reduce Medical Diagnostic Costs

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to develop technology that will substantially reduce the cost and complexity of ribonucleic acid (RNA)-based medical testing. Isolation of RNA from biological samples is the first and often the most difficult step in RNA diagnostic testing. All living things from bacteria to humans are threatened by viral infection and have strong natural defenses; these protein defenses are beneficial to humans but interfere with RNA testing. DNA contamination also interferes with RNA testing. As a result, there is a $2.3B market for reagents to clean-up protein and DNA contamination in RNA samples. The proposed product selectively isolates RNA from samples with near perfect selectivity, eliminating the need for these expensive RNA clean-up reagents. Simplification of the RNA isolation step has the broader impact of allowing for smaller and easier to operate devices that can be deployed to local clinics, allowing for easier and faster testing in point-of-care and rural settings. This SBIR Phase I project proposes to develop a new carbon-based coating for magnetic beads that selectively isolates RNA from samples with better yield than current products and without DNA or protein contamination. The company has developed a preliminary technology that performs better than competing products when used to isolate RNA from cultured cells. During this Phase I project, the material properties and usage protocols will be optimized to maximize performance in real-world applications, such as isolation of RNA from blood. The material properties as they relate to performance in this application will be studied using x-ray photoelectron spectroscopy (XPS) and optimized to maximize selectivity for RNA over contaminating molecules such as DNA and proteins. RNA will be isolated from diverse biological substances such as soft tissue, blood, and cell cultures, and each step in the process will be optimized to maximize yield and RNA integrity (RIN) while maintaining perfect purity as determined by northern blot, fluorescence spectroscopy, and qRT-PCR. The company also will begin to explore a manufacturing system for commercial production of the material.