Widening the Diagnostic Window

Courtesy Photo | Visual representation of SickStick’s ability to detect infection prior to overt flu symptoms. (Darwin Biosciences image)  

FT. BELVOIR, VA, UNITED STATES

11.07.2023

Courtesy Story

Defense Threat Reduction Agency's Chemical and Biological Technologies Department

Adversarial and naturally occurring biological threats pose a great risk to warfighters on the battlefield. In field-forward scenarios, rapid diagnostic capabilities against biological warfare agents are crucial for appropriate Joint Force health-protection measures. A new screening tool called SickStick does not require specialized training to use and aims to provide sample-to-answer results in 30 minutes or less.

Traditional point-of-care diagnostic tools are often limited to specific pathogens, demand specialized equipment, and require trained personnel. In this evolving threat landscape, there is a need for portable diagnostic and screening tools that can detect infections caused by a wide array of bacterial, viral, and fungal pathogens. In addition, platforms capable of alerting if an individual is infected and contagious before symptoms develop would enhance medical countermeasures, reduce mortality, and prevent disease spread.

The Defense Threat Reduction Agency’s (DTRA) Chemical and Biological Technologies Department in its role as the Joint Science and Technology Office (JSTO) for Chemical and Biological Defense, an integral component of the Chemical and Biological Defense Program, is investing in a project with Darwin Biosciences to develop a portable, noninvasive, point-of-care diagnostic tool for presymptomatic detection of infectious diseases. This technology combines a self-collected saliva specimen, isothermal RNA biomarker amplification, and detection on a lateral flow test strip into the fully integrated SickStick.

Darwin Biosciences specializes in the development of saliva-based diagnostics for the early detection of infectious diseases. Leveraging the innate immune system, Darwin Biosciences developed a panel of RNA biomarkers from early immune response pathways, which are broadly activated after exposure to diverse pathogens and precedes symptom onset. This approach allows for agnostic detection regardless of the causative agent and informs of an infection before symptoms develop. This technology will provide a unique early warning capability for pre-symptomatic detection of infection enhancing medical countermeasures, and preventing contagion risks amongst troops.

As part of this effort, DTRA JSTO is investing with the Laboratory Analysis and Clinical Evaluation Program to analyze RNA biomarkers developed by Darwin Biosciences and perform operational assessments of SickStick prototypes in partnership with Operational Infectious Diseases Directorate (OID) at the Naval Health Research Center (NHRC). The shipboard study was the first of its kind and resulted in successfully collecting 728 saliva samples from 66 crewmembers on USNS Comfort while forward deployed in the United States Southern Command Area of Responsibility in 2022. A second study onboard Comfort is scheduled for October 2023. NHRC is also conducting laboratory-based testing and operational use of SickStick prototypes. This data will be invaluable to further characterize and select relevant biomarkers for the SickStick platform. DTRA JSTO continues to facilitate the development of cutting-edge technologies that will enhance battlefield readiness and protect the Joint Force, our nation, and our allies from biological warfare agents.

POC: Stephanie Calderwood, Ph.D., [e-mail]

• Date Taken: 11.07.2023
• Date Posted: 11.07.2023 21:29
• Story ID: 457432
• Location: FT. BELVOIR, VA, US