The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for use in DXNA's Genestat detection platform.
The platform enables fast detection of the 2009 H1N1 influenza virus with a portable device weighing less than 10lb.
In the US, an Emergency Use Authorization (EUA) is a legal means for the FDA to authorise new medical devices or drugs during a declared public health emergency.
The central component of the Genestat platform is a device designed for portability and ease of use to detect 2009 H1N1 influenza virus where disease outbreaks are suspected instead of sending patient samples to distant reference laboratories.
A simple, non-invasive swab from the nose is used in the Genestat test module for detecting the virus.
