February 6, 2006

The FDA has approved a new laboratory test to detect avian influenza in patients suspected of being infected with the virus.

The test, developed by the Centers for Disease Control and Prevention (CDC), is called the Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set.

It provides preliminary results on suspected H5 influenza samples within four hours once testing begins, the FDA said. Previous tests required at least two to three days to render results. If the presence of the H5 strain is identified, further testing is conducted to identify the specific H5 subtype, the agency added.

The FDA approved the product just two weeks after CDC submitted its application -- an "extraordinarily short timeline," the FDA said. The FDA's expedited review process is designed to ensure new devices that have important public health benefits are available for use as quickly as possible, the agency said.

"Using flexible regulatory authorities, FDA was able to prioritize this expedited approval based on the clear critical need without compromising the quality or integrity of the FDA review process," said acting FDA Commissioner Andrew von Eschenbach.

This test will be distributed to Laboratory Response Network-designated laboratories to enhance early detection and surveillance activities as well as increase laboratory response capacity associated with a potential pandemic. Since December 2003, more than 160 human cases of avian flu caused by the H5N1 strain of influenza have been reported in Asia. More than half of these patients have died.

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