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DxNA Receives FDA’s Emergency Use Authorization For GeneSTAT

An integrated PCR-based influenza detection system for H1N1 virus

FDA has granted Emergency Use Authorization (EUA) for DxNA’s 2009 H1N1 influenza virus diagnostic test for use in its GeneSTAT detection platform. The new platform enables fast detection of the 2009 H1N1 influenza virus with a portable device weighing less than ten pounds.

The company claims that it has submitted its diagnostic test for FDA evaluation for the H1N1 swine flu strain of swine flu test using the GeneSTAT platform earlier this year. 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.

GeneSTAT diagnostic platform technology allows high complexity laboratories to conduct real-time diagnostic testing in a broad range of locations. The platform intends to make the PCR process easy to use for a clinical site. A non-invasive swab from the nose is used in the GeneSTAT test module for detecting the 2009 H1N1 influenza virus.

The company said that testing will not be limited to developed regions like the US, Europe and Japan, but is also possible in less-developed rural and economically challenged regions.

Phillip Grimm, president and chief executive officer of DxNA, said: “This new diagnostic test has the potential to significantly reduce the impact of 2009 H1N1 influenza by allowing for testing under appropriate laboratory conditions achievable even in a local hospital setting.”