Puteaux, France, December 9th, 2016 – ELITechGroup announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Zika ELITe MGB® Kit U.S. performed using the ELITe InGenius™ instrument, a fully automated sample-to-result system. This real-time PCR-based test utilizes ELITechGroup Molecular Diagnostics proprietary MGB Technology to target a highly conserved coding region for the qualitative detection of Zika virus RNA in serum or plasma from patients meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria.
The Zika ELITe MGB® Kit U.S. requires minimal operator intervention and hands-on time when performed on the ELITe InGenius™ instrument, which automates and integrates nucleic acid extraction, amplification, detection, and results reporting. Laboratories can run from 1 to 12 samples in a single run, generate results in 2.5 hours and reduce manual errors, with hands-on time limited to a few minutes.
The Zika ELITe MGB® Kit U.S. is the first IVD assay available for use on the ELITe InGenius™ instrument in the US. “This Emergency Use Authorization demonstrates our commitment to become an IVD solution provider in molecular diagnostics, leveraging on the ELITe InGenius™ system and the MGB technology, and is also a step forward in our expansion strategy into the US market”, said Christoph Gauer, CEO of ELITechGroup.
The Zika ELITe MGB® Kit U.S. performed on the ELITe InGenius™ instrument is for use only under Emergency Use Authorization (EUA) in CLIA-certified High Complexity Laboratories in the United States or similarly qualified non-U.S. laboratories. The Zika ELITe MGB® Kit U.S. and the ELITe InGenius™ instrument have not been FDA cleared or approved. The Zika ELITe MGB® Kit U.S. performed on the ELITe InGenius™ instrument 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 and/or diagnosis of Zika virus infection, unless the authorization is terminated or revoked sooner. This test has been authorized only for the detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens.