Emergency approval from FDA for new swine flu test

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Associated Press

Posted on November 10, 2009 at 7:25 PM

SAN DIEGO (AP) — 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 says 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.

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