FDA Grants Emergency Use Authorization For Quest H1N1 Test
24 Juillet 2009 - 8:22PM
Dow Jones News
The Food and Drug Administration Friday granted temporary
approval to an H1N1 influenza test made by a unit of Quest
Diagnostics Inc. (DGX).
Specifically, the agency granted a so-called Emergency Use
Authorization that allows unapproved products to be used in the
event of a public health emergency.
The FDA said the test, which is made by Focus Diagnostics, a
unit of Quest, is designed to test for the presence of the H1N1
influenza virus in genetic material obtained from swabs of
patients' noses or throats. The test is the third one granted an
Emergency Use Authorization since a public health emergency was
declared April 26, shortly after the new H1N1 virus was first
detected in the U.S.
The FDA said the test is meant to be used in certain
laboratories and wouldn't typically be used in a doctor's
office.
Earlier Friday the Centers for Disease Control and Prevention
said more than one million Americans are believed to have been
infected with the H1N1 virus and that 302 people have died.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com