The FDA has issued two emergency use authorizations for in vitro diagnostic devices used to detect the Zika virus.
In February 2016, the HHS determined Zika presented significant potential for a public health emergency. In light of this, the FDA has issued emergency use authorizations for DiaSorin’s Liaison XL Zika Capture IgM Assay and Nanobiosym Diagnostics’ Gene-RADAR Zika Virus Test.
The agency also revoked its authorization for Roche’s LightMix Zika rRT-PCR Test, at Roche’s request.