FDA Gives Emergency Authorization To Cepheid – H1N1 Test to Give Results in an Hour or Less
Posted Jan 04 2010 10:31pm
Detecting H1N1/Swine flu with the test has become a lot faster as the FDA has approved the use of the tests for hospitals, but the emergency provisions expire on April 26th. BD
Molecular diagnostics company Cepheid said Monday it received special Food and Drug Administration authorization to market a test that can detect swine flu in less than one hour.
The company said the FDA granted emergency use authorization to sell the Xpert Flu test, which can identify the 2009 strain of swine flu. The special authorization allows the test to be used in hospitals.
The test has not been approved by the FDA and is only authorized to be used until April 26 under the emergency use designation.