Pertussis is a respiratory disease caused by the bacterium Bordetella pertussis. It is airborne, highly contagious, and responsible for an annual 18 million illnesses and 250,000 deaths worldwide. Globally, pertussis is one of the leading causes of death for children under 5 years old. In the United States, the annual number of pertussis cases has been increasing since the early 1980s. Despite high vaccine coverage, there were still over 48,000 cases reported in the U.S. in 2012, which is the highest number since 1955.
Prompt diagnosis of early pertussis 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.
Pertussis is currently diagnosed by molecular approaches (e.g. PCR), culture, or serology (e.g. tests for patient antibodies). All of these approaches have limitations. Pertussis serology testing cannot be performed on infants and children who have been recently vaccinated. Culture requires waiting 5-7 days for bacterial colonies to grow. Molecular testing is expensive, typically requires specialized equipment and operator expertise, and frequently has a real-world turnaround time of 1-2 days from sample collection to result.
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 the rapid test for strep throat) that can detect B. 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.
The target population will be patients who present with symptoms of suspected pertussis. The serviceable available market is estimated at 500K patients per year in the U.S. and 50M patients per year worldwide.
DxDiscovery has been awarded Small Business Innovation Research (SBIR) Phase I and Phase II grants from the National Institute of Allergy and Infectious Diseases (NIAID) for development of the pertussis diagnostic.
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