Development Could Help Health Care Authorities Fight Current Outbreak of Deadly Disease.
ZURICH— Roche Holding AG said Monday it has received emergency authorization by U.S. drug regulators for an Ebola virus test, a development that could help health care authorities around the world fight the current outbreak of the deadly disease.
Basel-based Roche said in a statement that the U.S. Food and Drug Administration had authorized use of its LightMix (R) Ebola Zaire rRT-PCR Test on patients with signs and symptoms of the Ebola virus, and who met other risk factors, such as travel from West Africa, where the current outbreak is centered.
Roland Diggelman, chief operating officer at Roche’s diagnostics division, said the test would allow health-care professionals to quickly detect the virus and start patient treatment as early as possible.
The test is manufactured by Berlin-based TIB MOLBIOL GmbH and distributed exclusively by Roche. It can generate results in about three hours, but can only be used by certain laboratories during a limited period for the detection of the Ebola strain in the current outbreak, which is concentrated in Guinea, Liberia and Sierra Leone.
In an update published on Dec. 26, the World Health Organization said 7,693 people had died of confirmed, suspected or probable cases of Ebola in the three countries, while a total of 19,695 cases have been reported.