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FDA Approves New CDC MDx Panel for Seasonal, Pandemic Flu Strains

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The US Centers for Disease Control said late last week that its newest in vitro diagnostic testing panel for seasonal and pandemic influenza strains has been authorized for use by the US Food and Drug Administration.

CDC said that the new test kit, called the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, will be given at no cost to qualified international public health laboratories to improve global laboratory capacity for detecting influenza virus infections in human respiratory tract specimens.

The new kit comprises three modules, two of which are streamlined versions of previously approved CDC influenza molecular testing kits.

The first module is used to identify and distinguish between infection with influenza A and B viruses, a test that CDC originally received FDA approval for in 2008. The second module can further classify influenza A viruses by subtype, such as H1N1, H3N2, or 2009 H1N1. CDC first received Emergency Use Authorization from the FDA for a prior version of this module in 2009, followed by full FDA approval in June 2010.

The last module of the new test specifically detects highly pathogenic avian influenza A (H5N1) virus infection in human respiratory tract specimens in support of an ongoing global preparedness effort against a possible H5N1 bird flu pandemic, CDC said.

Previous versions of the CDC flu test were designed to run on Life Technologies' Applied Biosystems 7500 Fast Dx real-time PCR instrument.

According to the CDC, the modular design of the new test kit makes it more efficient for diagnostic laboratories by allowing users to order components separately, thus eliminating waste.

"This will lead to more efficient testing, with cost savings for the federal government and for state and local public health agencies," Nancy Cox, director of the CDC Influenza Division and of the World Health Organization Collaborating Center for Surveillance, Epidemiology, and Control of Influenza, said in a statement.

The test kit is used with specimens collected from a patient’s upper or lower respiratory tract, and is the only IVD for influenza that is FDA cleared for use with lower respiratory tract specimens, CDC said.

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