DxNA has announced that the company has submitted a request for Emergency Use Authorization (EUA) for its GeneSTAT pathogen platform to the FDA for the detection of the H1N1 virus (known as swine flu).
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.
The GeneSTAT platform incorporates 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 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.