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FDA Clears New H5N1 Test

The U.S. Food and Drug Administration on Tuesday cleared a new test developed by the Centers for Disease Control and Prevention for human influenza infections and the dangerous influenza A (H5N1) viruses. The Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel) uses a molecular biology technique on secretions taken from a person's nose or throat to detect flu virus and differentiate between seasonal and novel influenza, according to the release posted by HHS, which is CDC's parent agency.

FDA also cleared a diagnostic instrument called the Applied Biosystems 7500 Fast Dx that is used with the panel. It analyzes viral genetic material that has been labeled with fluorescent molecules by the panel.

"This is a significant achievement for public health surveillance," HHS Secretary Mike Leavitt said. "The test allows us to better support laboratories on the front line of influenza testing in the United States and abroad. This breakthrough allows for a more timely detection of a pandemic virus, which helps in determining when to begin broad control strategies, as well as life-saving mitigation measures such as closing schools, cancelling social gatherings, and informing businesses to begin work-at-home policies."

HHS said the test will be available to CDC-qualified laboratories this fall, and some labs will be able to obtain reagents for use in the testing process at no cost. "This new test provides us another tool in our toolbox to fight seasonal influenza, a virus that unfortunately kills thousands of people each year in the United States," CDC Director Dr. Julie Gerberding said. "We'll now be able to detect influenza in the community faster, which allows us to take steps more quickly to protect and save lives." CDC, Applied Biosystems of Foster City, Calif., and the Association of Public Health Laboratories collaborated on the development of the new test, while state public health labs in Virginia, Iowa, California, Massachusetts, Wisconsin, and Washington did clinical evaluations of the new flu panel.

For more information about H5N1 and seasonal flu, please visit this government site and CDC's homepage.

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