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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
June 26, 2007

Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Clears for Marketing First Quick Test for Malaria

The U.S. Food and Drug Administration has cleared for marketing the Binax NOW Malaria Test, the first authorized U.S. rapid test for malaria, a mosquito-borne disease caused by a parasite. The test is intended for laboratory use.

Standard laboratory tests for malaria require identifying parasites in a blood sample under a microscope, a difficult task that requires training and experience.

The Binax NOW test is significantly faster and easier to use. Results are available in 15 minutes after a few drops of whole blood are placed on a dipstick. The test can also differentiate the most dangerous malaria parasite, Plasmodium falciparum, from less virulent malaria parasites. Results still need to be confirmed using standard microscopic evaluation.

People infected with malarial parasites often experience a high fever, chills, and flu-like illness. Left untreated, they may develop severe complications and die.

Although malaria has been eliminated from the United States since the 1950s, it can still affect U.S. residents who travel or who work in other countries. According to the Centers for Disease Control and Prevention, there were 1,528 newly-reported cases of malaria in the United States in 2005,  including seven deaths. Nearly all deaths can be prevented if the infection is diagnosed and treated early.

"Since malaria is uncommon in the United States, clinicians and lab personnel may not be accustomed to diagnosing this disease," said Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "When used in combination with other laboratory tests, the Binax NOW test provides an additional tool to help them diagnose this disease faster in the United States."

The Binax NOW test was 95 percent accurate compared with standard microscopic diagnosis in a multi-center study outside the United States in areas where malaria is prevalent.

The Binax NOW test is manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc. of Scarborough, Me.

For more information on malaria consult CDC at www.cdc.gov/malaria/.

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