Cypress-Calif.-based Focus Diagnostics and Hamburg, Germany-based Altona Diagnostics requested the authorizations on behalf of their in-vitro diagnostic devices.
As a result of Zika’s threat to the public health and national security, the Department of Health and Human Services felt circumstances justified the authorizations. HHS also granted the authorization because there are no approved alternative diagnostic devices for Zika currently available.
The authorization allows for Altona’s RealStar Zika Virus RT-PCR Kit and Focus’ Zika Virus RNA Qualitative Real-Time RT-PCR test to be used for individuals showing clinical signs and symptoms of Zika, along with individuals who have recently traveled or had a history of residence in a geographic region known to have active Zika virus transmission.
While both devices detect RNA from Zika in the blood, Altona’s device can also diagnose through urine samples.
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