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FDA OKs Emergency Use of MDx Swine Flu Test; CDC Recommends MDx Testing

NEW YORK (GenomeWeb News) – The US Food and Drug Administration yesterday authorized the emergency use of a molecular diagnostic assay to identify cases of swine flu.

The test has not been cleared for marketing by FDA, but the agency granted the US Centers for Disease Control and Prevention the authority to use the multiplex panel to diagnose patients in the US. The rRT-PCR Swine Flu Panel is currently available through a small number of government labs.

"In authorizing an [Emergency Use Authorization] for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests," FDA said in a statement. "This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results."

FDA did not specify whether the test was internally developed at CDC or was developed by or in partnership with a commercial entity. FDA officials did not return a call to GenomeWeb Daily News seeking further information by the time this article was published.

Meanwhile, CDC has released a series of interim guidance documents related to the swine flu outbreak, which has sickened patients in at least 11 countries, with the number of confirmed cases in the US currently standing at 50. One of those CDC guidance documents relates to testing for swine flu — and CDC specifically recommended real-time PCR testing for influenza A, B, H1, and H3 at a State Health Department Laboratory.

"Currently, swine influenza A (H1N1) virus will test positive for influenza A and negative for H1 and H3 by real-time RT-PCR," it said in the guidance.

CDC also noted that confirmation of swine flu is currently performed at CDC, but it "may be available in state public health laboratories soon."

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