Biocartis To Develop Rapid Ebola Virus Triage Test

Test developed for IdyllaTM aims at fast and accurate diagnostics in challenging environments

Mechelen, Belgium, 10th February 2015 - Biocartis today announces 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.”

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For more information, please contact:

Biocartis
Rudi Pauwels, CEO
Hilde Windels, CFO
+32 15 632 600 (Mechelen, Belgium)
nhutsebaut@biocartis.com

Consilium Strategic Communications
Amber Bielecka/Jessica Hodgson/Chris Welsh/Laura Thornton
+44 (0) 203 709 5701 (London, UK)
biocartis@consilium-comms.com

About Biocartis (www.biocartis.com )

Biocartis has developed an innovative and proprietary molecular diagnostics ("MDx") platform that offers accurate, highly-reliable molecular information from any biological sample, enabling fast and effective diagnostics, treatment selection and treatment progress monitoring. Biocartis is using its CE-IVD marked Idylla™ platform to develop and market a broad set of high value clinical assays in the oncology and infectious diseases segments.

Biocartis' market opportunity is driven by an increasing use of MDx in the management of cancer, complex infectious diseases, and other severe conditions and, in particular, the growing adoption of personalized medicine that requires advanced diagnostics tests to be carried out rapidly and cost effectively when and where key clinical decisions are made. Currently, most clinical molecular testing involves a series of complex, labor intensive, time-consuming and relatively costly steps (each of which needs to be conducted in a specialized, dedicated laboratory environment), including the preparation of clinical samples, isolation of human or pathogenic genetic material (such as DNA) from the sample, amplification, detection and quantification of this genetic material, and result delivery and interpretation. Biocartis' products fully automates these otherwise complex and costly steps, enabling low volume, high clinical value molecular testing to take place at the point-of-need. Biocartis focuses on assays in the fields of oncology and infectious diseases, the two largest application areas in MDx.

About personalized medicine & molecular diagnostics

Every person has a unique genetic profile. Understanding and leveraging the molecular mechanisms underlying diseases empowers doctors to shift away from the one-drug-fits-all paradigm and tailor a treatment to the genetic profile of their patient, also known as ‘personalized medicine’. Specific molecular diagnostics tests can, for instance, aid a doctor in the selection of the appropriate therapy for a melanoma patient whose tumor carries a specific genetic mutation. Eventually, this makes treatments more effective, improves outcomes and ultimately reduces healthcare costs. However, in order to be truly sustainable and beneficial, molecular information needs to be gathered quickly and easily, at the point of need. Today, this is not the case. Most hospitals do not perform molecular tests in-house, but send the test samples out to specialized labs where they are processed in batches, on multiple instruments and operated by highly trained personnel. This time-consuming and labor-intensive process delays treatment decisions that are often crucial to save patients’ lives.

About Idylla™ (www.idylla.com)

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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