Portable and ruggedized infection diagnostic platform providing rapid, clinically actionable pathogen detection at deployed locations and military treatment facilities

The Department of the Air Force (DAF) faces a critical challenge in ensuring the health and mission readiness of its forces amid the persistent threats posed by infectious diseases. To provide timely and effective tracking, containment, and treatment of infectious diseases for DAF service members on various operations that span across the globe, there is a critical need for a rapid and reliable diagnostic solution capable of identifying infectious pathogens at deployed locations and forward environments. DxLab has developed a portable and ruggedized molecular diagnostic platform called the DxHub that is ready to respond to this need. The DxHub utilizes a highly efficient and sensitive nucleic acid amplification technology to quickly detect even a small amount of targeted pathogens in crude, unprocessed samples at the point-of-care (POC), and it has obtained the emergency use authorization (EUA) from the FDA for POC detection of SARS-CoV-2, the virus that causes COVID-19. The proposed SBIR Phase II project aims to enhance the DxHub’s technical capabilities and demonstrate its suitability for a specific DAF use case, namely POC detection of major respiratory viruses from a single patient sample. During the proposed SBIR Phase II project, the development of a new DxHub test for the detection of targeted respiratory viruses will focus on achieving sensitivity, specificity, and time-to-result that are required for the DAF end-users, aiming to offer performance that is on par with or better than existing laboratory-based diagnostic testing options. High-throughput testing capability and reproducibility will also be evaluated in a field setting, outside of a centralized laboratory, with non-laboratory trained operators, and the DxHub system will be refined as necessary to achieve desired performance in the field. The respiratory panel test that will result from the proposed SBIR Phase II project will allow for rapid and reliable POC detection of major respiratory viruses to not only improve the DAF’s ability to diagnose and treat respiratory infections across a wide range of duties, but also track and monitor respiratory tract infections around the globe for more comprehensive disease outbreak analysis and control.