FDA approves Roche test for emergency use on patients with signs and symptoms of Ebola
Roche Holding AG said U.S. health regulators have approved its Ebola test for emergency use in response to the world’s worst outbreak of the disease in West Africa.
The U.S. Food and Drug Administration (FDA) has approved Roche’s LightMix Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection, the Swiss drugmaker said in a statement.
Roche said the LightMix test can generate results in just over three hours, helping to detect the virus quickly so treatment can start as soon as possible.
Under the emergency use designation, certain laboratories in the United States and other countries have been authorized to use the test for a limited period to detect the type of Ebola that has been spreading in West Africa.
The test, made by TIB MOLBIOL GmbH and distributed by Roche, has not been approved by the FDA for general use.
The global death toll from Ebola has risen to 7,588 out of 19,497 confirmed cases recorded in the year-old epidemic in West Africa, the World Health Organization said last Wednesday.
(Reporting by Caroline Copley. Editing by Jane Merriman)