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Siemens Zika Test Receives FDA Emergency Use Authorization

NEW YORK (GenomeWeb) – Siemens Healthcare Diagnostics announced today that the US Food and Drug Administration has granted Emergency Use Authorization (EUA) for the firm's real-time PCR Zika virus assay.

Siemens' Versant Zika RNA 1.0 Assay (kPCR) Kit can detect the presence of Zika virus and be an earlier indicator than anti-Zika antibodies of Zika virus infection, the company said.

The molecular test is validated for plasma, serum, and urine collected alongside a patient-matched serum or plasma specimen from people meeting the US Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria or the CDC's Zika virus epidemiological criteria, or both.

According to Siemens, the test runs on its Versant kPCR Sample Prep automated platform along with several commercially available thermal cyclers.

The assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus or diagnosis of Zika virus infection, or both, the firm said.

The Siemens test is the latest addition to a range of Zika tests to receive EUA. As reported by GenomeWeb, tests developed by Viracor-IBT, Hologic, Altona Diagnostics, Quest Diagnostics, and the CDC have all received the EUA label.

Ubiquitome is also developing Zika tests with an application for EUA in mind.