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FDA Approves 1st Permanent Swine Flu Test

 
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The first diagnostic test for 2009 swine flu has been approved for permanent use, the U.S. Food and Drug Administration announced Monday.

Several tests were cleared on a limited basis during the swine flu-related public health emergency, but the new Simplexa Influenza test from Focus Diagnostics in Cypress, Calif., is the first to come though the traditional approval system, the Associated Press said.

To detect the H1N1 virus, the Simplexa test analyzes specimens from nasal swabs.

The FDA approval means the test will still be available when the H1N1 public health emergency expires, said Jeffrey Shuren, director of the FDA's center for devices.

Between 43 million and 88 million swine flu cases occurred in the United States between the spring of 2009 and March 2010, the government estimates.

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