DxNA announced today that the FDA has granted Emergency UseAuthorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for usein DxNA’s GeneSTAT(TM) detection platform. The new platform enables fastdetection of the 2009 H1N1 influenza virus with a portable device weighingless than 10 pounds. In the United States, an Emergency Use Authorization(EUA) is a legal means for the FDA to authorize new medical devices or drugsduring a declared public health emergency. “This new diagnostic test has the potential to significantly reduce theimpact of 2009 H1N1 influenza by allowing for testing under appropriatelaboratory conditions achievable even in a local hospital setting,” saysPhillip H. Grimm, President and Chief Executive Officer of DxNA LLC.DxNA submitted its diagnostic test for FDA evaluation for the H1N1 NovelSwine Flu strain of Swine Flu test using the GeneSTAT platform earlier thisyear. The central component of the GeneSTAT platform is a device designed forportability and ease of use to detect 2009 H1N1 influenza virus where diseaseoutbreaks are suspected instead of sending patient samples to distantreference laboratories. A simple, non-invasive swab from the nose is used inthe GeneSTAT test module for detecting the 2009 H1N1 influenza virus.Through it’s relatively fast, PCR genetic testing capabilities, GeneSTATtechnology facilitates the detection of viruses. The World HealthOrganization has highlighted rapid detection of pandemics such as swine flu as”crucial” for the rapid implementation of measures “to stop the pandemic atits source and to prevent millions of deaths, social disruption, and economicloss.” One European virologist has pointed to the fact that the currentlack of local testing may mean more people have been infected with a pandemicthan originally suspected and pointed to PCR as the most desirable diagnosticmethod for local testing purposes.
