Roche receives Emergency Use Authorization from FDA for its LightMix Ebola Zaire rRT-PCR Test

Swiss drug major Roche (ROG: SIX) has received Emergency Use Authorization for its LightMix Ebola Zaire rRT-PCR Test from the US Food and Drug Administration.

The test is to be used on individuals with signs and symptoms of Ebola Zaire virus infection, in conjunction with epidemiological risk factors, such as people traveling from West Africa. It is used to detect Ebola Zaire virus in whole blood samples using the large installed base of Roche’s LightCycler 480 or cobas z 480 instruments.

Roland Diggelman, chief operating officer of Roche Diagnostics Division, said: "The LightMix Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for health care professionals to quickly detect the virus and start patient treatment as early as possible. As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. The FDA's granting of this EUA supports our commitment to healthcare professionals working to combat this deadly disease."