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FDA OKs Roche Zika test for emergency use

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Sept. 13, 2016—The Food and Drug Administration has issued an emergency use authorization for Roche‘s LightMix Zika rRT-PCR Test. The product is for use in patients meeting CDC Zika virus clinical criteria 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 its Cobas z 480 Analyzer.

“The LightMix Zika test is an easy-to-use molecular diagnostic test that enables health care professionals to quickly detect the virus,” Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. “As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging health care 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 protocol to initiate collection and testing of blood samples for screening. It is being used in U.S. blood centers.

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