Roche Receives Emergency-Use Permission From FDA for Ebola Test
(Bloomberg) — Roche Holding AG said it got permission from the U.S. Food and Drug Administration for emergency use of a test to detect the type of Ebola that has been spreading in West Africa.
Certain laboratories in the U.S. and other countries have been authorized to test people during a limited period with the LightMix Ebola Zaire rRT-PCR Test, Basel, Switzerland-based Roche said in a statement today. The test, made by TIB Molbiol GmbH and exclusively distributed by Roche, doesn’t have FDA approval.
The LightMix test can generate results in about three hours, Roche said.
To contact the reporter on this story: Thomas Mulier in Geneva at tmulier@bloomberg.net To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Tom Lavell
