MeMed has developed MeMed BV Flex, a rapid infection differentiation test that distinguishes between bacterial and viral infections.
This test is set to widen the accessibility of MeMed BV to decentralised, Clinical Laboratory Improvement Amendments (CLIA)-waived settings, using a few drops of blood from a finger prick to deliver results within 15 minutes.
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Designed for near-patient use, the test operates on an improved version of MeMed’s current platform.
It has been verified in a prospective analytical trial, showing performance on par with laboratory methods.
According to the published study, measurements of capillary and venous blood demonstrated high concordance in terms of all the host proteins examined, along with the MeMed BV score, suggesting that there is alignment between the sample types.
The company noted that a multi-centre pivotal trial is currently underway to support regulatory submission and confirm clinical accuracy, following initial discussions with the US Food and Drug Administration (FDA).
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By GlobalDataBy using host response data, MeMed BV aims to aid physicians with the information needed to make informed treatment decisions and decrease needless antibiotic use.
MeMed CEO and co-founder Eran Eden said: “Accurately and simultaneously measuring multiple proteins from just a few drops of blood, in a rapid and easy-to-use format, has been a long-standing challenge.
“By pairing this breakthrough with machine learning, we’ve enhanced our platform, which, once cleared, can help extend host-response testing across broader decentralised use. It’s a major step toward our next goal of reaching one million patients and enables a plug-and-play engine for our broader pipeline, from MeMed Severity to future sepsis and immune-status assays.”
Last year, MeMed secured the FDA’s breakthrough device designation for its MeMed Severity test, which is designed to improve the management of patients with suspected acute infections and sepsis.
