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Siemens to Release RUO Zika Test While Seeking Emergency Use Authorization

Mar 02, 2016
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Madeleine Johnson
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NEW YORK (GenomeWeb) – Siemens Healthcare Diagnostics has developed a real-time PCR assay for Zika virus and intends to apply for Emergency Use Authorization for the test in the US.

The test, which is currently for research use only, is designed to run on Siemens' Versant kPCR molecular diagnostic platform, but can also be performed on other qPCR platforms. However, Siemens also plans this month to launch the sample prep module of the Versant platform in the US as a registered Class I device which can be paired with the Zika test.

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