SBIR Phase II: Automated One-Hour Testing for Bacterial Detection and Antibiotic Sensitivity in Clinical Samples

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to deliver a rapid antibiotic susceptibility testing (AST) platform, toward revolutionizing the diagnosis and treatment of infections across a variety of specimen types, including urine, cerebrospinal fluid (CSF), and wound effluent. The AST platform will enable rapid identification of effective antibiotics for treating infections such as urinary tract infections (UTIs), urosepsis, meningitis, and wound infections, and significantly reducing morbidity and mortality. The novel AST platform will enable identification of appropriate antibiotics for a given infection within an hour. This will reduce the need for empirical antibiotic administration and address the urgent public health challenge of increasing antimicrobial resistance, where the potential to reduce the empirical use of broad-spectrum antibiotics could slow the development of antibiotic resistance. Commercialization associated with this project has significant potential to impact nearly all facets of AST and clinical diagnostics toward guiding treatment with quantitative results rather than empirical observation, where adoption is expected in emergency rooms, primary care facilities, and specialty clinics. The AST market is projected to reach US$ 4.05 Billion by 2028 and a novel AST device would be well positioned to address critical market deficits. This Small Business Innovation Research (SBIR) Phase II project is focused on developing a novel rapid antibiotic susceptibility testing (AST) platform, the first of its kind designed to perform AST across various critical specimen types such as urine, cerebrospinal fluid (CSF), and wound effluent, delivering results in under an hour. Traditional methods, which are based on culture techniques, often take several days, causing delays in administering the correct antibiotics for infections and adversely affecting patient outcomes. To avoid the wait for AST results, clinicians frequently resort to prescribing broad-spectrum antibiotics empirically, which contributes to the growing problem of antibiotic resistance. There is a significant need for rapid AST methods that can quickly determine the most effective antibiotics, especially for critical conditions like urinary tract infections (UTIs), complicated UTIs, urosepsis, bacterial meningitis, and skin and wound infections. The goals of this project are to 1) adapt a previously developed urine cartridge for use in CSF and effluent specimen types; 2) characterize analytical parameters for detection of relevant bacterial strains in urine, CSF, and effluent; and 3) complete clinical verification of the AST platform with urine, CSF, and effluent clinical specimens. 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.