Roche Receives FDA Authorization for Zika PCR Test
News Aug 30, 2016
Roche has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the LightMix® Zika rRT-PCR Test. The product is for use in patients meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria.
The test is used for the detection of Zika virus in EDTA plasma or serum samples using Roche’s LightCycler® 480 Instrument II or cobas z 480 Analyzer.
“The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics.
“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 help healthcare professionals who are working to combat this serious disease.”
In addition to the LightMix® Zika rRT-PCR Test, Roche has also developed the cobas® Zika Test for use with the cobas® 6800/8800 Systems. This test is available under an Investigational New Drug Application (IND) protocol to initiate collection and testing of blood samples for screening. It is currently being utilized in blood centres in the United States.