FDA Gives Emergency Approval For H1N1 Test
New Test Can Diagnose Swine Flu In As Little As 3 Hours
Posted: 7:50 am PDT October 29, 2009Updated: 8:41 am PDT October 29, 2009
SAN DIEGO -- Gen-Probe Inc. said Thursday the Food and Drug Administration granted emergency approval to its diagnostic test for the 2009 swine flu. The test maker said the FDA approved its Prodesse ProFlu-ST test, which Gen-Probe said can diagnose swine flu in as little as three hours, while tests using throat cultures can take weeks. The FDA decision does mean not full marketing approval and lasts only for the duration of the declared public health emergency related to swine flu. The emergency is set to expire on April 26, 2010. Gen-Probe is scheduled to report its third-quarter results after the market closes on Thursday. In morning trading, its shares rose 29 cents to $41.86.
Copyright 2009 by The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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