Company's 4.5kg "Lab in a Box" Allows for Rapid Onsite Pathogen Detection
ST. GEORGE, Utah, April 29 /PRNewswire/ -- DxNA announced today that in response to the recent outbreak of swine flu and related world threat, it is developing a diagnostic test for its GeneSTAT(R) pathogen detection platform to detect the H1N1 virus (known as swine flu) anywhere it is needed in approximately 45 minutes using a portable device that weighs less than 10 pounds. The Company anticipates having a product ready for evaluation in 1-2 weeks.
"Such mobile testers can be used by anyone, with the most basic training," says John Crowther of the Joint FAO/IAEA Program's Animal Production and Health section. "The results could immediately be processed back to a central point, like a mobile phone message. Such tests could revolutionize disease diagnosis."
DxNA also announced today that it will request the U.S. Food and Drug Administration (FDA) to grant an Emergency Use Authorization for the H1N1 strain of Swine Flu test using the GeneSTAT platform.
DxNA initially developed its rapid, portable molecular test to detect H5 Avian Influenza for markets around the world. That test is now being validated by the Chinese government and other global health organizations. The GeneSTAT platform includes a device that offers portability and remote usage to rapidly detect pathogens where outbreaks are suspected. The user-friendly device is also suitable for use in gateway airports, at local health departments and schools, where on-site, rapid and non-invasive screening for highly contagious pathogens is advised. The GeneSTAT test module requires a simple swab of the mouth, nose or throat. The Company is developing a number of follow-on tests to detect pathogens that may affect people and agriculture.
"We are in early market release of our first GeneSTAT product, for avian flu, with validation currently underway by labs in both the United States and overseas," said Phillip Grimm, Chief Executive Officer of DxNA. "We are now focused on the swine flu pathogen, and have reached out to health agencies around the world and offered our assistance in helping to rapidly diagnose this virus."
Through its rapid, precise, on-site polymerase chain reaction (PCR) genetic testing capabilities, GeneSTAT technology facilitates the rapid detection of pathogens and 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 rapid field tests may mean more people have been infected with a pandemic than originally suspected and pointed to PCR as the most efficient diagnostic method for field testing.(2)
DxNA's GeneSTAT diagnostic platform technology allows individuals with approximately five minutes of training to conduct accurate real-time diagnostic testing almost anywhere. With the GeneSTAT platform, PCR - previously performed in large clinical laboratories by highly-skilled personnel - can be performed by almost anyone, in virtually any location, including airports, laboratories, clinics, or physician's offices. Furthermore, testing is not limited to developed regions like the United States, Europe and Japan but also 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. The Company's systems and technologies enable rapid and precise genetic testing to take place on-site by allowing for otherwise complex, manual, laboratory procedures to be performed anywhere.
DxNA, together with its distinguished advisory board consisting of Nirbhay Kumar, Ph.D., Paul Blumenthal, Ph. D., Anthony R. Torres, M.D., and Richard Webby, Ph.D., is working to commercialize its GeneSTAT diagnostic technology for rapid PCR detection applications throughout the world. For more information, please visit www.DxNA.com.
(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)
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