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Luminex Gets FDA OK for Swine Flu Data in xTAG Panel

NEW YORK (GenomeWeb News) – Luminex today said that the US Food and Drug Administration has cleared labeling updates for its xTAG Respiratory Viral Panel to include data about the performance of the test in humans infected with the pandemic A/H1N1 influenza virus, also known as swine flu.

The labeling will now include information from two studies that Luminex said shows that xTAG RVP can be an effective aid in detecting the virus, but cannot identify the hemagglutinin gene of the 2009 influenza A/H1N1 in clinical specimens.

"The studies now referenced in the xTAG RVP package insert demonstrate that the test can help determine if a patient is carrying a typical, seasonal respiratory virus or an unsubtypeable flu A virus," Luminex President and CEO Patrick Balthrop said in a statement.

The firm's xTAG RVP was initially cleared by FDA in January 2008. The multiplex test can simultaneously detect 12 respiratory viruses and subtypes, including influenza A with subtyping, at the DNA/RNA level.

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