Simplexa H1N1 Test Approved
MONDAY May 24, 2010 -- The Simplexa diagnostic test to detect infection with the H1N1 "swine" flu virus has been approved by the U.S. Food and Drug Administration, the agency said Monday in a news release.
Prior to the approval, the test was available under the agency's Emergency Use Authorization, which allows the FDA to sanction use of unapproved medical products during a public health emergency. The agency declared such an emergency on April 26, 2009, and the new approval permits the test's continued use after the emergency declaration expires.
The test uses nasal specimens to detect the presence of the H1N1 virus, although it does not indicate the infection's severity.
The first wave of H1N1 hit the United States in the spring of 2009, followed by a second wave last fall. As many as 88 million people were infected in the United States through March 13, the FDA said.
The Simplexa test is produced by Focus Diagnostics Inc., of Cypress, Calif.
The U.S. Centers for Disease Control and Prevention has more about H1N1 flu.
Posted: May 2010