FDA OKs 2009 H1N1 influenza test for use beyond emergencies

June 23, 2010

FDA has cleared Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection.

FDA has cleared Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection.

Until now, tests for 2009 H1N1 influenza were only available through an Emergency Use Authorization (EUA), which allows FDA, after evaluating available data, to authorize the use of unapproved or uncleared medical products, or unapproved or uncleared uses of approved or cleared medical products, when a declaration of emergency is in effect. EAUs expire when HHS declares an end to a public health emergency.

In April 2009, the Department of Health and Human Services (HHS) declared a public health emergency resulting from the H1N1 influenza virus.

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

Using specimens from nasal swabs or nasal aspirates, the test, which is manufactured by Focus Diagnostics Inc. of Cypress, Calif., simultaneously amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that a 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 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.