SBIR Phase I: Integrated Point-of-Care System for Rapid Pathogen Identification in Urinary Tract Infections

Nanopath Inc., Cambridge MA

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is improved access to state-of-the-art molecular diagnostic technologies in areas of significant unmet clinical need, such as women’s health. Urinary tract infections (UTIs) are a pressing problem due to the lengthy clinical workflows and large disease incidence. UTIs are one the most common prompts for women to seek health care in the United States and represent a major driver of antibiotic prescriptions. Untreated UTIs can lead to severe complications for the patient, such as systemic bacterial infections. Despite the severity and prevalence of UTIs, diagnostic methodologies remain extremely time-consuming and rely on antiquated culture-based detection, leaving women in pain for up to three days before they are prescribed the appropriate antibiotic therapy. The proposed project will accelerate UTI diagnosis and can be used for other infections as well. This Small Business Innovation Research (SBIR) Phase I project integrates microfluidic methods for cell enrichment with a novel nanostructured substrate for ultrasensitive detection of target nucleic acid sequences. The reader contains software and optical hardware to detect and analyze the test result at the point-of-care. This technology eliminates the need for bacterial culture and nucleic acid amplification through an ultrasensitive detection modality, providing species-level information and genotypic antibiotic resistance data within minutes. The applications of this proposed platform translate beyond UTIs and have utility in other clinical scenarios that currently employ lengthy culture-based steps and molecular testing workflows, such as respiratory infections, bloodstream infections, and prosthetic joint infections. The project goal is to increase sample throughput through microfluidics optimization and automation and to improve sensitivity through novel sensor geometry design. 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.