PROJECT SUMMARY Approximately 40% of the world’s population, 2.5 billion people, are at risk of contracting dengue fever. The disease is endemic to tropical regions in Central and South America, Africa, and Asia. Outbreaks have also occurred in the southern portions of the United States, including Florida and Texas, as well as the Hawiian islands.The FDA has approved a single vaccine against dengue. Both safety and efficacy of the vaccine depend on whether or not the recipient has been previously exposed to the dengue virus. The potential for severe dengue disease in seronegative individuals receiving the vaccination (especially for children ages 2-4) underscores the need for a field-deployable device to determine if individuals have previously been infected by the dengue virus. There is a concern that a universal vaccination program could have deleterious effects on populations living in regions where infection is the norm. Thus, a rapid, economical, point-of-care (POC) assay to determine if an individual has been exposed to the virus will be significant. Data from this assay will assist the medical community in establishing an anti-dengue vaccination protocol. Lynntech proposes to develop a portable, highly sensitive, and highly specifc diagnostic that is capable of detecting anti-dengue antibodies in human samples. Anti-dengue antibodies will be specifically recognized and captured by high affinity ligands, resulting in the generation of an electrochemical signal reflecting pre- exposure to the dengue virus. The Lynntech system will offer a straightforward, POC means to assess the serological profile of individuals with respect to their previous exposure to the dengue virus. The global need for such an assay bolsters market potential for the Lynntech product.

PROJECT NARRATIVE Lynntech proposes to develop a rapid, economical, POC assay to determine if an individual has been previously exposed to the dengue virus. This is necessary since vaccination by Dengvaxia, the only FDA- approved dengue vaccine, can result in severe dengue disease in seronegative individuals.