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FDA Grants Emergency Use Authorization for IMDx H1N1 Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has granted emergency use authorization for IntelligentMDx's (IMDx) test for the 2009 H1N1 flu virus, the Cambridge, Mass.-based company said today.

The emergency use authorization does not clear the company's Influenza A H1N1 Real-Time RT-PCR Assay for use beyond the period of the 2009 H1N1 influenza public health emergency, which is currently scheduled to expire on April 26, 2010, unless it is renewed or terminated sooner.

The authorization for the test, which takes around 90 minutes to produce results, includes its use on the Applied Biosystems 7500 system, 7500 Fast Real-Time PCR Systems, and the 7500 Fast Dx Real-Time PCR systems. The authorization covers use of the tests only by CLIA high complexity laboratories to detect and differentiate the 2009 Influenza A H1N1 virus.

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