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FDA Approves Focus Diagnostics 2009 H1N1 Influenza Virus Test

FDA has cleared California-based Focus Diagnostics manufactured Simplexa Influenza A H1N1 (2009) test to identify 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.

Until the clearance, tests for 2009 H1N1 Influenza were only available through an Emergency Use Authorization (EUA), which allows the FDA, based on the evaluation of available data, to authorise the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.

Reportedly, on April 26, 2009, the US Department of Health and Human Services declared a public health emergency due to the 2009 H1N1 Influenza Virus. EUAs for devices will cease to be effective when the public health emergency declaration expires.

According to Focus Diagnostics, using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The US Centers for Disease Control and Prevention estimates that between 43 million and 88 million cases of 2009 H1N1 occurred between April 2009 and March 13, 2010.

Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA, said: “With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires.”