FDA Grants Emergency Use For H1N1 Detection Device<
DxNA has announced that the United States Food and Drug Administration has granted Emergency Use Authorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for use in DxNA’s GeneSTATTM detection platform. According to the company, the new platform enables faster detection of the virus in a portable composition that weighs less than 10 pounds. An EUA is the legal means for the FDA to authorize new medical devices or drugs during a declared public health emergency.
“This new diagnostic test has the potential to significantly reduce the impact of 2009 H1N1 influenza by allowing for testing under appropriate laboratory conditions in a local hospital setting,” says Phillip H. Grimm, President and Chief Executive Officer of DxNA LLC.
DxNA submitted its diagnostic test for FDA evaluation for the H1N1 Novel Swine Flu strain of Swine Flu test using the GeneSTAT platform earlier this year. A simple, non-invasive swab from the nose is used in the test module for detecting the virus.