SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug maker Roche Holdings (RHHBY.PK) announced Monday that the U.S. Food and Drug Administration has issued an Emergency Use Authorization or 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 cobasz 480 Analyzer.
Roche noted that the LightMix Zika rRT-PCR Test has not been FDA cleared or approved. It has been authorized by the FDA under an EUA for use by certified laboratories to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens.
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 or IND protocol to initiate collection and testing of blood samples for screening. It is currently being utilized in blood centres in the United States.
Uwe Oberlaender, Head of Roche Molecular Diagnostics, said, 'The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus... The FDA's granting of this EUA supports our commitment to help healthcare professionals who are working to combat this serious disease.'
The LightMix Zika rRT-PCR Test is manufactured by TIB MOLBIOL GmbH and exclusively distributed by Roche.
The test was developed to run on the LightCycler 480 Instrument II or cobas z 480 Analyzer. The end-to-end automated process from sample preparation to results for up to 96 samples can be performed in just 2.5 hours.
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