DxNA Submits Its Rapid Detection Platform Test For H1N1 To FDA

DxNA announced 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.

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