Issue: Currently, disease diagnosis depends upon items such as clinical presentation (e.g., fever, cough), which can be coupled with laboratory work (e.g., swab test for COVID-19, strep throat culture). There is currently no diagnostic means to preemptively determine if someone is infected with bacterial or viral disease (in a broad sense) prior to the onset of symptoms and target-specific testing. This is a challenge for diseases such as COVID-19 that have a long incubation period or have asymptomatic presentation, and which can have a similar clinical presentation to completely different pathogens- whether in a specific or additive manner.
Objective: This project supported the development of a hand-held, portable, device that can identify infections in people before they show symptoms, as well as differentiated between viral and bacterial infections in less than one hour. The device is a battery-powered and fully integrated system that could provide rapid identification of infected and infectious individuals. The Cross-Border Threat Screening and Supply Chain Defense (CBTS) Center of Excellence project with Predigen and Biomeme developed a point-of-care diagnostic device in a CLIA-waivable form for the detection of pre-symptomatic bacterial/viral host gene expression test.
Value Proposition: Earlier detection of individuals with viral and/or bacterial infections improved triage decisions that helped to curb the spread of infectious diseases, particularly if that screening was successful prior to the presentation of clinical symptoms or in asymptomatic people. In such instances, appropriate public health measures could be put in place to prevent/limit disease spread, including further testing and treatment when possible. The ruggedized platform has received an Emergency Use Authorization during this project from the Food and Drug Administration (FDA), and is being used in some industries to screen workers and promote safer work environments.
Paul Mitis, Ph.D., Biomeme Inc. senior molecular biologist