Pertussis is a respiratory disease caused by the bacterium Bordetella pertussis. It is 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.
Pertussis incidence in the United States 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.
Diagnostic challenges. One of the most significant obstacles to alleviating the domestic and international disease burden of pertussis is early and effective diagnosis. Patient treatment and outbreak containment can be effective, but only if initiated early.
Pertussis is currently diagnosed by bacterial culture, PCR or serology. Unfortunately, these assays are all slow, expensive, or require specialized equipment and operator expertise. Currently, rapid and inexpensive diagnostic tests for early-stage pertussis are not available.
DxDiscovery solution. We aim to overcome this challenge by developing a rapid, point-of-care diagnostic test for early pertussis. The diagnostic test is intended for widespread use in children who show non-specific, cold-like symptoms of early-stage disease, which appear well before development of the characteristic “whooping” cough. Early diagnosis will allow for effective treatment and will prevent unnecessary spread of infection within the community.
The product will be a lateral flow (dipstick) assay that can detect the B. pertussis bacterium in infant nasopharyngeal swabs in <15 min, at very low cost, and without specialized equipment or user expertise. Acceptance and widespread adoption of the test by the medical community will be rapid because the dipstick testing format is already used routinely to diagnose strep throat in pediatrician offices.
Market opportunity. There is no comparable test in the healthcare market. The target population will be infants who present with the non-specific, respiratory tract infection symptoms of early pertussis (prior to onset of the whooping stage). The number of such children in the United States will be in the millions of patients per year. Globally, the number of potential patients will be in the tens to hundreds of millions.
R&D funding. A Phase I small business innovation research (SBIR) grant from the National Institute for Allergy and Infectious Diseases (NIAID) was awarded to DxDiscovery for early-stage development. All of the Phase I project’s research milestones were met, and DxDiscovery successfully competed for Phase II SBIR funding NIAID for further development of the lateral flow immunoassay. The Phase II award provides for an R&D budget of $1M over three years.