SBIR Phase I: A Novel Diagnostic for Identification of Sepsis Inducing Pathogens

This Small Business Innovation Research (SBIR) Phase I project aims to establish the feasibility of a novel assay which would enable the culture-free identification of sepsis inducing pathogens and their resistance traits. Sepsis is a one of the leading causes of morbidity and mortality in the US with over 210,000 annual mortalities. The key to treating sepsis properly is rapid and accurate identification of the causative pathogen. Unfortunately, given the wide range of potential pathogens which can induce sepsis, the ?gold-standard? today for diagnosis remains culturing; which typically requires up to 3-5 days for accurate identification leading to a significant delay in the initiation of a targeted treatment protocol. The technical research will demonstrate the ability of using synthetic DNA analogues in a specific manner which could provide a method to circumvent the need to culture in order to properly identify the causative pathogen. If successful, this assay would provide a significant improvement to the current norm ? reducing the extremely high mortality rates as well as reducing healthcare related costs. The broader impact/commercial potential of this project is to address a major barrier to improving patient outcome in cases of sepsis ? the need to culture. Over 700,000 patients will be diagnosed with sepsis this year, and roughly 30% will not survive ? the need is apparent. The economic impact is likewise exceedingly high, roughly $24B, due to the prolonged hospital stay. As the primary determinant of patient outcome is the timely choice of the appropriate therapy ? by reducing the time to pathogen identification to hours instead of days, patient outcome will be drastically improved as well as a reduction in hospital related costs due to a reduction in disease severity. The assay proposed in the project has been designed to utilize instrumentation and technical competencies already in place in the hospital lab. The combination of improved patient outcome, a reduction in hospital related costs, and a product design facilitating a straightforward adoption, promises significant and rapid market penetration. There are no other methods available that offer the range of capabilities, the simplicity of use, and the compatibility to test for multiple pathogens and resistance genes like the proposed assay.