SBIR Phase II: Rapid Sepsis Screening System Based on Pathogen DNA Extraction

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to reduce the time that it takes to identify positive sepsis patients. The type of sepsis-causing pathogen will also be determined by this test, which will aid in guiding correct antibiotic treatment. The device under development is expected to reduce the need for cultures by directly testing a patient’s sample for infectious pathogens. Sepsis morbidity increases by about 7% for each hour that correct treatment is delayed, so the device under development in this project, which greatly reduces the diagnostic time, is reasonably expected to increase the survival rate for sepsis patients. This Small Business Innovation Research (SBIR) Phase II project intends to advance the commercialization of a diagnostic lab instrument that uses a novel method of extracting pathogens and their DNA (deoxyribonucleic acid). Additionally, a pathogen class-specific analytical DNA test is also being developed to classify the type of infection that may be identified from the extracted patient sample. This two-step sepsis screening test is simpler and far faster than any current test for sepsis pathogen identification. The extraction device automatically combines a precisely controlled pH shock to the blood sample, human DNA elimination, filter-based pathogen capture and washing, ultrasonic disruption/DNA extraction, and automated elution of extracted pathogen DNA. The extracted elution is then directly and immediately used with the companion PCR (polymerase chain reaction) test, specifically developed for this application, which runs on standard, open-platform instruments already available in 80% of U.S. hospital labs. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.