LYNNTECH INC. — Department of Defense SBIR Phase II: DHA202-002

Description

Shigella infection is one of most common medical problems for deployed military personnel. Shigella infection causes acute diarrheal as well as chronic functional bowel disorders and reactive arthritis, and the infection keeps our service members out of fight, threatening unit readiness. Therefore, the need of prevention of Shigella infection has become a high priority for US Service Members. Both vaccine and non-vaccine countermeasures will need reliable assays to show product efficacy. Any successful countermeasure product will need to be highly efficacious against multiple Shigella serotypes. The bactericidal activity of Shigella antibodies has been used as a measure to evaluate the functional activity of antibodies. However, conventional bactericidal activity assay is based on counting the surviving bacterial forming units on plates through overnight culture, which is labor-sensitive, time-consuming, and not suitable for large-scale studies. To test the antibody against multiple serotypes, the assay must be performed on each serotype and large qualities of samples are needed. A qualified, multiplexed, high-throughput antibody bactericidal assay against an array of Shigella strains will save time, lower supply cost, and reduce biological sample volume needed. Lynntech proposes to develop a rapid, high-throughput, and cost-effective multiplex assay capable of simultaneously evaluating bactericidal activity of antibodies against multiple Shigella serotypes. This assay is being designed to be simple and has the capability to provide sample-to-answer results in few hours instead of two days. In the preceding Phase I effort, Lynntech has obtained compelling proof-of-concept by demonstrating the multiplexity of our assay using two Shigella serotypes. This Phase II project will build upon the work done in Phase I and focus on optimizing and expanding our multiplex assay to simultaneously measure antibody activities against 5 Shigella serotypes. During the Phase II effort, Lynntech will conduct initial activities to facilitate eventual commercialization of our multiplex assay.