Biocartis' test for detecting Ebola approved by the FDA

01/06/2016

The test that can be used for early detection of the Ebola virus, developed by the Mechelen-based biotechnology company Biocartis, has just received the green light from the U.S. Food and Drug Administration (FDA). This authorisation allows tests and research by U.S. laboratories, which is significant progress in combating the virus.

This is a molecular diagnostic test for the Ebola Zaire virus which was co-developed by Biocartis NV, Janssen Diagnostics (a division of Janssen Pharmaceutica NV) and the Belgium Institute of Tropical Medicine that co-discovered the Ebola virus 40 years ago. The test detects the Ebola Zaire virus in one hundred minutes. Biocartis has received "Emergency Use Authorisation" from the FDA for the test.

Ebola is a viral disease in humans caused by the Ebola virus. The disease is rare and appears in the form of regional outbreaks in Central and West African countries. The epidemic that struck West Africa in 2014 was the largest since the virus' discovery. On this occasion, this highly infectious disease caused over 11,000 deaths in several of the region's countries. The disease has a high mortality rate and there is currently no specific treatment or drug available against the virus. Experts expect further outbreaks of the virus to return in the future.

In the past, Biocartis has developed several tests for detecting cancer. The Ebola test is the second test for the detection of infectious diseases developed by the Mechelen-based biotechnology company.