DxNA Submits its Rapid Detection Platform Test for H1N1 to FDA
Company's Portable 4.5kg "Lab in a Box" Allows for Rapid Onsite Pathogen Detection
ST. GEORGE, Utah, June 9 /PRNewswire/ -- DxNA announced today that it has submitted a request to the FDA for Emergency Use Authorization (EUA) for its GeneSTAT(R) pathogen platform, for the detection of the H1N1 virus (known as swine flu). EUA allows for the early availability of important diagnostic and therapeutics tools to diagnose, treat, or prevent critical or life-threatening diseases or conditions, when an alternative or approved solution is not available(1).
"Those touched by the flu are becoming increasingly aware that there is no accessible test for the H1N1 virus and that the currently available methods lack the capability to process large volumes of cases. We believe the availability of such a test would help assure concerned patients and families that they are taking the appropriate steps in combating this growing threat as cases continue to increase," said Phillip Grimm, Chief Executive Officer of DxNA. "This regulatory path provided by FDA allows early access to products with great potential like our GeneSTAT pathogen test platform, which we believe can provide a quick and efficient method to detect the H1N1 virus."
Although the period of review can vary by product profile, existing applications, and nature of the emergency, the FDA acts upon EUA submissions in an expedited manner to potentially bring life-changing diagnostic and therapeutic tools to the public.
DxNA has also developed a 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(R) platform includes a portable device that offers remote usage to rapidly detect pathogens where outbreaks are suspected. The user-friendly device can be used 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(R) 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.
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(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, M.D., M.P.H., 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.