Inverness gets 510(K) clearance for BinaxNOW diagnostic test to include avian flu

By E. Janene Geiss

Philadelphia, Dec. 19 - Inverness Medical Innovations announced Monday that its wholly owned subsidiary Binax Inc. obtained 510(K) clearance from the U.S. Food and Drug Administration for a new claim with the BinaxNOW Influenza A & B Test.

The test now includes avian influenza H5N1 isolates in its list of influenza strains, according to a company news release.

Avian influenza, commonly referred to as "Bird Flu," is an infectious disease caused by type A strains of the influenza virus. The BinaxNOW one-step rapid influenza test is able to clearly differentiate between influenza A and influenza B in 15 minutes, officials said.

Use of this easy-to-read rapid test can help diagnose patients efficiently in the event that an influenza outbreak should occur, officials said.

A confirmed diagnosis helps guide health care providers in the selection of appropriate treatments, such as administration of antiviral medication. Antivirals can reduce the severity of symptoms, shorten the duration of the illness and reduce the time period when patients who are ill with influenza are infectious to others.

These capabilities are particularly relevant when the window of opportunity to effectively implement antiviral therapy is only 48 hours from the onset of symptoms.

Inverness Medical Innovations is a Waltham, Mass., developer of in vitro diagnostic products.

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