Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has provided an Emergency Use Authorization (EUA) for the LightMix® Ebola Zaire rRT-PCR Test for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa. The test is used for the detection of Ebola Zaire Virus in whole blood samples using the large installed base of Roche's LightCycler® 480 or cobas z 480 instruments.
"The LightMix® Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for healthcare professionals to quickly detect the virus and start patient treatment as early as possible," said Roland Diggelman COO, Roche Diagnostics Division. "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."
The LightMix® Ebola Zaire rRT-PCR Test has also been CE marked by the test's manufacturer, TIB MOLBIOL GmbH, and is available for use on the LightCycler® 480 or cobas z 480 instruments in markets accepting the CE mark. In addition, TIB MOLBIOL GmbH has submitted an Expression of Interest (EOI) for Emergency Assessment by the World Health Organization Prequalification of the In vitro Diagnostics Programme.