Swine Flu “Emergency” Test in an Hour

Silicon Valley company to help FDA

With the swine flu still causing something near a panic for the healthcare industry, Washington is turning to Silicon Valley for help.

On Monday afternoon, the FDA granted Sunnyvale, Calif. biotech company Cepheid a rare "emergency use authorization" for Cepheid's Xpert Flu Panel test, which can detect the H1N1 strain of the flu virus.

The test still isn't FDA-approved, per se. But the agency can grant a company an emergency authorization for a certain period of time, if it thinks the product in question meets a pressing need -- in this case, the need to diagnose H1N1 quickly.  Cepheid says its Xpert Test can identify H1N1 in less than an hour.

Conventional tests can take 12 hours just to identify a flu virus of nonhuman origin -- a possible indicator of swine flu -- and then require more testing, a process which can delay results for days.

The authorization, which runs through April 26, will let Cepheid sell the test to hospitals, which are eager to improve the speed of H1N1 diagnosis. Because the test is self-contained, it won't require sending samples out to a lab.

Cepheid executives say they're happy with the decision, but understand that it's not full FDA approval.  They will continue to seek it as they ramp up production of Xpert kits for the coming months.

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