Roche wins FDA emergency approval for Ebola test
Roche Holding AG has received permission from the U.S. Food and Drug Administration for emergency use of a test to detect the type of Ebola that has spread through West Africa.
Roche’s LightMix Ebola Zaire rRT-PCR test is able to generate results in just over three hours.
A test called RT-PCR, which stands for reverse transcriptase polymerase chain reaction, is now in use to diagnose the disease. The test uses DNA analysis to detect the disease and typically takes about six hours to return results.
The LightMix’s fast turnaround allows “healthcare professionals to quickly detect the virus and start patient treatment as early as possible,” said Roland Diggelman, COO of Roche Diagnostics Division.
The FDA has granted an emergency use designation, which means that certain lab facilities in the U.S. and other countries are able to use the test for a limited period. The LightMix test, which is being produced by TIB Molbiol GmbH, hasn’t been approved for general use.
The current Ebola outbreak is the world’s worst to date. The global death toll has grown to 7,588, and almost 19,500 patients have been infected since the epidemic took hold in West Africa nearly a year ago, according to the World Health Organization.