SBIR Phase II: Integrated Point-of-Care System for Rapid Pathogen Identification and Characterization

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is improved access to state-of-the-art molecular diagnostic technologies in areas of significant unmet clinical need, such as women’s health. During the NSF I-Corps Program, the team identified urinary tract infections (UTIs) as pressing problem due to the currently lengthy clinical workflows, significant unmet clinical need, and large disease incidence. UTIs are one the most common causes of a healthcare visit for women in the United States and represent one of largest sources of antibiotic prescriptions in the country. Untreated UTIs can lead to severe complications for the patient, including systemic bacterial infections such as bacteremia. Despite the severity and prevalence of UTIs, diagnostic methodologies remain extremely time-consuming and rely on antiquated, culture-based methodologies for pathogen detection. This time-intensive diagnostic workflow typically leaves women in pain for up to three days before they are prescribed the appropriate antibiotic therapy. As a result of shortcomings in current healthcare workflows, women who have limited access to care are subject to longer result wait times, and often never receive the appropriate treatment. This Small Business Innovation Research (SBIR) Phase II project utilizes a novel nanosensor embedded into an integrated diagnostic consumable for rapid detection of target nucleic acid sequences directly from patient samples. The consumable is coupled to a proprietary bench-top readout instrument for test analysis and result reporting at the point-of-care. The technology eliminates the need for bacterial culture and nucleic acid amplification through an ultrasensitive optical detection modality, providing species-level information and genotypic antibiotic resistance data within minutes. Applications of the proposed platform translate beyond UTIs to other clinical scenarios that currently employ lengthy culture-based or amplification-based diagnostic workflows, such as sexually transmitted infections and respiratory infections. Successful product commercialization will require meeting clinically actionable timescales and assay performance benchmarks. Of importance is the development of a simple, integrated workflow for healthcare workers to enable single-step operation at the point-of-care. The Phase II technical objectives focus on the development and pilot-scale fabrication of the nanosensor, the optimization of sensitivity and robustness of data analysis methodologies to inform down-selection of reader optical hardware, and system integration and user testing. 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.