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Zika RNA assay receives EUA from FDA

The U.S. FDA has granted Siemens an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika IVD tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, among other circumstances, there are no adequate, approved, and available alternatives and certain additional criteria are met. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, and is designed to run on the Siemens VERSANT kPCR Sample Prep automated platform, along with several commercially available thermal cyclers. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is only authorized for use for the duration of the declaration that circumstances exist justifying the eua.

Supplier: Siemens Healthineers

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