Body Language

Courtesy Photo | A graph showing how to interpret the bacterial vs. viral (BV) score. A score closer to 0 indicates a high likelihood of viral infection or other non-bacterial etiology. A score closer to 100 indicates a high likelihood of bacterial infection or co-infection. (MeMed image)  

FT. BELVOIR, VIRGINIA, UNITED STATES

04.11.2023

Courtesy Story

Defense Threat Reduction Agency's Chemical and Biological Technologies Department

Biomarkers of the body’s natural responses indicate whether an infection is viral or bacterial. MeMed’s Key is the latest way to listen to what the body is telling us.

A new diagnostic test can quickly determine if an illness with a fever is caused by a bacterial versus a viral infection, an important distinction in speeding up administering the appropriate treatment. Additionally, it also can help reduce the further emergence of antibiotic-resistant bacteria, which is a serious global health threat. The test is a host immune-response diagnostic tool and is performed on a new antibody analyzer by the Israel-based company MeMed called the Key.

Antibiotics do not treat viral infections and, if wrongly prescribed, can instead kill the body’s good bacteria or cause bad bacteria to become antibiotic resistant, making future bacterial infections more difficult to treat. Viral infections, such as the flu and COVID-19, can be treated with antivirals but not antibiotics.

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 invested in MeMed to support the research team in developing a technology that uses the body’s response to the infection to identify the cause rather than look for a specific bacteria or virus.

The new technology uses machine learning to integrate measurements of three key host-immune proteins into a score indicating the likelihood of bacterial or viral infections. This score, called BV, for bacterial vs. viral, has been measured and shown to be accurate in over 20,000 patients.

Prior to DTRA JSTO’s investment, MeMed had already begun looking for biomarkers of infection to use in a rapid test. Through their preliminary work, the research team identified three biomarkers they could measure using a laboratory test called an Enzyme-Linked Immunosorbent Assay (ELISA) and an algorithm that combined these measurements into a score indicating bacterial versus viral infection—the BV score. The MeMed group validated the diagnostic accuracy of the BV score in various clinical studies with different populations and in different countries where the performance was compared to reference standards. While the ELISA test is sensitive, it takes up to three hours to complete and requires trained technicians to perform it.

The ELISA provided a proof of concept to measure the identified biomarkers, but MeMed wanted a faster and easier method to measure and report the results. With DTRA JSTO’s investment, MeMed developed an analyzer that measures proteins using magnetic particles and a reagent to detect chemiluminescence, which is a robust method to get the precise and reproducible measurements they needed.

Other studies conducted on adults confirmed the pediatric studies and gave the team the confidence they had a BV score that MeMed could license for clinical use. Consequently, the team started another clinical study performed on American patients using MeMed’s newly developed analyzer in several U.S. urgent care centers and emergency departments, and two Israeli emergency departments. After a thorough review, the Food and Drug Administration gave both the analyzer and the single-use, disposable BV cartridge full clearance.

This new diagnostic tool illustrates how DTRA JSTO can more quickly detect biologic threats against the Joint Force and administer effective treatments. Warfighters and civilians alike will be able to receive a quicker and more accurate diagnosis of their illnesses, leading to appropriate treatments, diminishing the administration of improper medications, and helping reduce the further emergence of antibiotic resistance.

POC: Stephen Francesconi, Ph.D., [e-mail]

• Date Taken: 04.11.2023
• Date Posted: 04.11.2023 16:41
• Story ID: 442429
• Location: FT. BELVOIR, VIRGINIA, US