A Novel Host-Protein Point of Need Platform for Differentiating Bacterial Versus Viral Infections: Transition from Prototype to Product

Posted March 23, 2022

Eran Eden, Ph.D., MeMed

Dr. Eran Eden with the MeMed teams in the U.S. (headquarters in Boston, top) and Israel (headquarters in Haifa, bottom)
Figure 1: Dr. Eran Eden with the MeMed teams in the U.S. (headquarters in Boston, top) and Israel (headquarters in Haifa, bottom)

Differentiating bacterial and viral infections can be difficult for medical providers because patients often present with similar symptoms and common diagnostic tests can take hours or days to generate results. Because of this, some patients are prescribed unnecessary antibiotic treatments, which cannot treat viral infections, reduce healthy gut bacteria, and contribute to antimicrobial resistance. Additionally, identifying and treating infections in military environments can be particularly troublesome due to limited medical diagnostic tools and treatment supplies. This is further complicated when the infection site is blocked or inaccessible. To address these limitations, modern diagnostics focus on identifying the body’s immune response to infection, rather than identifying the bacterial or viral pathogen itself. As blood samples are easily accessible, blood tests that measure the body’s immune response can provide rapid results and could address issues at the point of care (i.e., length of time for diagnosis, sample acquisition) and reduce the unnecessary use of antibiotics for viral infections.

With support from a Fiscal Year 2016 Technology/Therapeutic Development Award through the Peer Reviewed Medical Research Program (PRMRP), Dr. Eran Eden and his team at MeMed aimed to advance their device to differentiate between bacterial and viral infections from a proof of concept to a U.S. Food and Drug Administration (FDA)-cleared diagnostic test and platform. Their technology, which was previously supported by the Defense Threat Reduction Agency, detects three proteins (TRAIL, IP-10, and CRP) produced by the immune system and generates results from a serum sample in just 15 minutes. Funds from this PRMRP award supported scale-up of the materials production, including the cartridge for running the MeMed BV® test and the MeMed Key® Platform, while meeting Good Manufacturing Practices as required by the FDA. In a trio of blinded clinical validation studies the MeMed BV test achieved highly accurate results.1  The team conducted an additional clinical study (“APOLLO” study, NCT04690569) to confirm the performance of the device and ensure that the device met regulatory requirements.2  With this data, the MeMed BV and MeMed Key received 510(k) clearance from the FDA in September 2021 for their combined ability to distinguish between bacterial and viral infections with high accuracy.3  By providing 510(k) clearance, the FDA agrees that the MeMed BV and MeMed Key are at least as safe and effective as other marketed devices with the same intended use and that the device can be sold in the United States.

MeMed BV test and MeMed Key platform
Figure 2: MeMed Key platform (top right) and MeMed BV test (bottom left).

The MeMed BV and MeMed Key are also Conformité Europëenne (CE)-Marked and available in Europe and Israel. The devices’ innovative approach earned MeMed Diagnostics a 2019 World Economic Forum Technology Pioneer Award and a 2019 Frost & Sullivan European Diagnostic Solutions Technology Leadership Award.4,5  In January 2022, MeMed secured an additional $93 million in venture capital funds to accelerate the production of the devices.6  Dr. Eden further plans to evaluate the MeMed BV proteins for early detection of general viral infection and to predict disease severity. This includes efforts to combat the COVID-19 pandemic by predicting deterioration when triaging at the front line. The technology could have a major impact on distinct populations, including children, for whom bacterial or viral symptoms can be less clear than for adults and infections can easily spread to others (e.g., at school). Most significantly, the MeMed BV and MeMed Key are being developed for use at the point of need, rather than at a clinical laboratory, allowing for better-informed treatment decisions. The MeMed Key is less than 1 cubic foot in volume and approximately 22 pounds, which could allow the device to travel for use in military or other resource-limited environments. With their rapid detection, ease of use, and portability, the MeMed BV and MeMed Key are poised to make a powerful impact on the health of Service Members, Veterans, and the American public.









Public and Technical Abstracts: A Novel Host-Protein POC Platform for Differentiating Bacterial Versus Viral Infections: Transition from Prototype to Product

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Last updated Wednesday, March 23, 2022