Roche Holding AG on Monday 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, approved Roche’s LightMix Ebola Zaire rRT-PCR test for use on patients with signs and symptoms of Ebola Zaire virus infection.
Roche said the LightMix test could generate results in just over three hours, helping to detect the virus quickly so treatment could start as soon as possible.
Under the emergency use designation, certain laboratories in the U.S. and other countries have been authorised 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 World Health Organisation said that 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.