While we’re still waiting for the fabled sensitive, specific and fast point-of-care H1N1 test, here is a step in the right direction.
You see, the burden of H1N1 is felt far beyond those stricken with the disease — every day, hundreds if not thousands of patients with infections (that may or may not be swine flu) wait in US emergency departments while their inpatient bed assignments are determined by the results of a slow, unreliable swab test. Do they need an isolation bed? They’ll wait hours to find out, and the results may not even be that accurate.
But the FDA is helping the situation along, with this recent announcement:
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.
The small and lightweight kit works as a module in the GeneSTAT system, a portable tabletop instrument about the size of a coffee machine.
More from DxNA (which is a terrific name for a company that makes DNA diagnosis equipment)…
Demo video of the DxNA’s GeneSTAT system: