Prompt diagnosis of early pertussis (Whooping cough) is critical for minimizing the extent and economic burden of pertussis outbreaks. Specifically, timely contact tracing and deployment of prophylactic antibiotics to high-risk close contacts depends on the swift diagnosis of pertussis cases. Rapid diagnosis of pertussis also facilitates antibiotic stewardship and optimal patient care by enabling the immediate initiation of antibiotic therapy to infected individuals and by preventing unnecessary antibiotic administration to uninfected individuals.
To address the unmet clinical need for rapid diagnosis of pertussis at the point of care, we have developed a lateral flow immunoassay (similar in format to rapid COVID-19 tests) that can detect Bordetella pertussis bacteria from nasopharyngeal specimens (i.e. swabs and washes). The assay provides results in less than 20min and is designed to be simple and robust enough to be used not only in hospital emergency department settings, but also at the point-of-care in urgent care clinics, pediatrician offices, and clinics in resource-limited settings.
In Phase I of this project, which was funded by a small business innovation research (SBIR) grant from the National Institute of Allergy and Infectious Disease (NIAID), we identified several candidate biomarkers of pertussis infection and developed prototype immunoassays to detect them (ELISA and lateral flow). A Phase II award was then made to DxDiscovery from NIAID for further development of an advanced, point-of-care, monoclonal antibody-based diagnostic and for the device’s evaluation with animal model and patient samples. A Phase IIB award from NIAID has now been received by DxDiscovery to complete the final research and development of the prototype diagnostic and to perform the pre-clinical and clinical studies needed for FDA regulatory review of the device. Dr. Burnham-Marusich is the Principal Investigator for the project.