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Biocartis to Develop Rapid Ebola Virus Triage Test

Biocartis announced that it is in the testing phase of a Rapid Ebola Virus Triage Test that it is developing in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp (Belgium) for its Idylla system, a fully automated molecular diagnostic platform that is CE-IVD marked in Europe.

The Rapid Ebola Virus Triage Test is designed to enable healthcare workers, even in challenging environments, to test blood samples and aims at providing accurate and fast diagnosis of Ebola. The test is designed to offer a unique combination of speed, sensitivity, accuracy and ease-of- use required for outbreaks where time is of the Essence.

The test uses 0,2 ml blood that is added directly to the Idylla cartridge, which contains all necessary reagents on board for performing the analysis on Biocartis fully automated, molecular diagnostics system. A complete analysis of the sample takes around 90 minutes and can be operated by healthcare professional in most settings, including in the field, making the test ideal for use in regions with limited Infrastructure.

Biocartis believes its Rapid Ebola Virus Triage Test could provide a sustainable solution for rapid detection of Ebola-infected patients even after the current Ebola outbreak. After testing of synthetic virus samples in Belgium and the US, Biocartis has now registered for field-testing in West Africa to gather additional clinical evidence for the test Performance.

Rudi Pauwels, Biocartis chief executive officer commented: This test aims not only to improve the diagnosis of the Ebola virus for hard-pressed healthcare professionals in the field, but to lay the foundations for a better and faster diagnostic infrastructure after the current outbreak has receded, both in this region and around the world. One of the lessons of the Ebola outbreak has been the urgent need for faster and more accurate diagnostics. Biocartis is pleased to be working, alongside prestigious partners, on what it believes could offer a viable solution for healthcare workers around the world to enable faster testing of infectious diseases in virtually any setting.

The Idylla platform, launched as a CE-marked product in September 2014, is a fully- automated, self-contained real-time polymerase chain reaction based MDx system, designed to offer physicians fast access to highly reliable MDx information. The Idylla platform is differentiated by its ability to perform tests on-demand in virtually any setting, from any biological sample type without the need for pre-processing, and its capacity to detect multiple biomarkers from a single sample. The Idylla platform covers the entire process from sample to result in 35 to 150 minutes (depending on the type of assay), with a hands-on time of around two minutes.

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