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Roche to initiate testing for Zika virus at U.S. Blood Centres under FDA Investigational New Drug Application protocol

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Additional Relevant Details Food and Drug Administration (FDA) has provided approval to initiate collection and testing of blood samples for screening with the cobas Zika assay under an Investigational New Drug Application (IND) protocol. The cobas Zika test for use with the cobas 6800/8800 Systems, is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors.
http://www.fda.gov/N...
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Catalyst Date
Occurred on:
Mar 31, 2016
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Related Keywords Zika Virus, Nda, Cobas 6800/8800 Systems