FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization

The U.S. Food and Drug Administration  announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.

Until this 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 authorize 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.

On April 26, 2009, the U.S. 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.

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

Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test simultaneously 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 United States experienced its first wave of 2009 H1N1 Influenza Virus in the spring of 2009, followed by a second wave in the fall. The U.S. 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.

The Simplexa Influenza A H1N1 (2009) test is manufactured by Focus Diagnostics Inc. in Cypress, Calif.

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