Biocartis secures FDA emergency use authorisation for Idylla Ebola Virus Triage test

1 June 2016 (Last Updated June 1st, 2016 18:30)

Belgium-based molecular diagnostics company Biocartis has secured the Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its Idylla Ebola Virus Triage Test (Idylla EBOV Test) to detect the Ebola Zaire virus in patients.

Ebola

Belgium-based molecular diagnostics company Biocartis has secured the Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its Idylla Ebola Virus Triage Test (Idylla EBOV Test) to detect the Ebola Zaire virus in patients.

Developed in collaboration with Biocartis, Janssen Diagnostics (a division of Janssen Pharmaceutica NV) and the Belgium Institute of Tropical Medicine, the Idylla EBOV Test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test, which gives results within 100 minutes on a single cartridge, compatible with the Biocartis Idylla platform.

The Biocartis Idylla platform is a fully automated, sample-to-result, real-time RT-PCR system designed for a quick implementation irrespective of the infrastructure of nations.

In 2014, the Ebola virus outbreak in West Africa claimed 11,000 lives and affected several nations which prompted the necessity to establish an enhanced infectious disease surveillance and management.

Biocartis founder and CEO said: "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.

"We are very pleased to collaborate with Johnson & Johnson, as well as the Institute of Tropical Medicine in a joint effort towards improved readiness for disease outbreaks.

"The Idylla Ebola Virus Triage Test is the first infectious disease outbreak test authorised 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."

"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."

The test will detect the occurrence of Ebola Zaire virus in patients exhibiting symptoms of Ebola from the 2014 West Africa outbreak.

The Idylla Ebola Virus Triage Test involves entering a blood sample into the Idylla cartridge, the cartridge then becomes a hermetically closed container.

The enclosed container protects the healthcare workers from being exposed to the virus.

Additionally, the test requires minimal training of healthcare professionals and can be transported and stored at ambient temperature conditions allowing a rapid implementation during emergency situations.


Image: A man delivering the Idylla Ebola Virus Triage Test. Photo: courtesy of Biocartis.