FDA Grants Emergency Use Authorization for DxNA's GeneSTAT(TM) Integrated PCR-based Influenza Detection System for H1N1 Virus Groundbreaking 4.5kg "Lab in a Box(TM)" to Provide Fast H1N1 Virus Detection
ST. GEORGE, Utah, Dec. 14 /PRNewswire/ -- DxNA announced today that the United States 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(TM) detection platform. The new platform enables fast detection of the 2009 H1N1 influenza virus with a portable device weighing less 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 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 achievable even 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. 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 2009 H1N1 influenza virus.
Through it's relatively fast, PCR genetic testing capabilities, GeneSTAT technology facilitates the detection of viruses. The World Health Organization has highlighted rapid detection of pandemics such as swine flu as "crucial" for the rapid implementation of measures "to stop the pandemic at its source and to prevent millions of deaths, social disruption, and economic loss."(1) One European virologist has pointed to the fact that the current lack of local testing may mean more people have been infected with a pandemic than originally suspected and pointed to PCR as the most desirable diagnostic method for local testing purposes.(2)
DxNA's GeneSTAT diagnostic platform technology allows high complexity laboratories to conduct efficient real-time diagnostic testing in a broad range of locations. The GeneSTAT platform, with an enclosed, user-friendly format, intends to make the PCR process easy to use for a clinical site. Furthermore, testing will not be limited to developed regions like the United States, Europe and Japan, but also possible in less-developed rural and economically challenged regions. Designed with economy in mind, GeneSTAT is inherently less costly than the PCR devices typical of large clinical laboratories.
DxNA, based in St. George, Utah, and with offices in New York City is a groundbreaking molecular diagnostics company that develops and distributes portable, fully-integrated systems and tests for genetic analysis in the medical, agricultural, and biosecurity markets. DxNA initially developed its rapid, portable molecular test to detect H5 Avian Flu for markets around the world and is also developing tests for malaria, tuberculosis, human papilloma virus, Group B strep and other diseases. The Company's systems and technologies enable rapid and precise genetic testing to take place at different locations by allowing for otherwise complex, manual, laboratory procedures to be performed with less operator input.
(1) "Global Surveillance During an Influenza Pandemic, Version 1" World Health Organization Global Influenza Programme, April 2009, http://www.who.int/csr/disease/swineflu/global_pandemic_influenza_surveilance_apr09.pdf (Accessed April 29, 2009)
(2) "Testing for Swine Flu No Easy Feat," Reuters, April 29, 2009 http://tvnz.co.nz/health-news/testing-swine-flu-no-easy-feat-2685198 (Accessed April 29, 2009)