WASHINGTON — The Food and Drug Administration says it has approved the first diagnostic test for 2009 swine flu under its traditional approval system.
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The FDA previously cleared several tests on a limited basis for use during the declared public health emergency related to swine flu.
The new Simplexa Influenza test from Focus Diagnostics in Cypress, Calif., uses specimens from nasal swabs to detect the H1N1 virus.
Jeffrey Shuren, director of the FDA's center for devices, says the FDA clearance means the availability of the Simplexa H1N1 test will not be affected when the public health emergency expires.
The federal government estimates between 43 and 88 million cases of swine flu occurred between April last year and March 2010.
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