FDA Clears First H1N1 Test

The FDA has cleared the Simplexa Influenza A H1N1 (2009) virus test, which had only been available under an Emergency Use Authorization (EUA) granted by the agency. Because HHS had declared a public health emergency for H1N1 last April, the EUA allowed the diagnostic to be used before it received formal FDA clearance. The clearance permits the use of the test, manufactured by Focus Diagnostics, after the health emergency expires, the FDA says.