Biocartis’ Ebola test approved for emergency use

June 1, 2016 News BioVox

The U.S. Food and Drug Administration (FDA) has granted Biocartis’ Ebola Virus Triage Test emergency use authorization. The test was developed in collaboration with Janssen Diagnostics and the Institute of Tropical Medicine, which also discovered the virus 40 years ago.

The Ebola detection assay is remarkably simple: a blood sample of a suspected patient is added to the detection cartridge, which is then inserted into Biocartis’ diagnostic platform Idylla™. Within roughly an hour and a half, the test provides accurate results. The cartridges are hermetically sealed after addition of the sample, limiting healthcare worker exposure to the virus, and no specially trained lab personnel is needed to carry out the test. Idylla’s compactness also make is very suitable for use in remote locations.

The Ebola outbreak of 2014 was the largest ever, and although the worst of the outbreak has passed, experts expect sporadic flare-ups and possible outbreaks of Ebola in the future.

Rudi Pauwels, Biocartis CEO, commented: “The 2014 Ebola and more recently the Zika outbreak, demonstrates that in today’s global world we need rapid, highly accurate and easily deployable diagnostic systems. The Idylla™ Ebola Virus Triage Test is the first infectious disease outbreak test authorized by the FDA on our Idylla™ platform, which is – thanks to its unique features – perfectly suited for outbreak control through early and fast testing. The test allows healthcare professionals in the field to rapidly diagnose infection, implement control measures and as such, open doors to faster and better treatment decisions.”

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