Compliance Management

FDA Grants "Emergency Use" Approval for Ebola Test

Dec 30, 2014


Roche Holding AG said the U.S. Food and Drug Administration approved its Ebola test for emergency use, according to a Reuters article. Roche's LightMix Ebola Zaire rRT-PCR Test was approved for use on patients with signs and symptoms of Ebola Zaire virus infection. The LightMix test is said to generate results in just over three hours, helping to detect the virus quickly.

The article states that 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. Read the full article