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NEW YORK - Swiss drug giant Roche said Monday that U.S. health regulators granted emergency approval to its diagnostic test for the 2009 swine flu.
The Food and Drug Administration approved the company's RealTime H1N1 detection kit to help diagnose swine flu.
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.
Roche will compete against a number of other diagnostics companies marketing H1N1 tests, including Gen-Probe Inc. and Quest Diagnostics Corp.
Swine flu has sickened about 22 million Americans since April and killed nearly 4,000, according to the latest federal estimates.
Fewer than 42 million doses of vaccine are currently available in the U.S., a few million less than federal officials previously estimated.
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