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Roche (RHHBY) Receives FDA Emergency Use Authorization for LightMix Zika rRT-PCR Test

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Roche receives FDA Emergency Use Authorization for Zika PCR test

August 29, 2016 1:00 AM EDT

PLEASANTON, Calif., Aug. 29, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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... More