FDA Clears Rapid Test for Malaria

Associated Press | 27 Jun 2007
Houston Chronicle
The Food and Drug Administration on Tuesday said it approved Inverness Medical Innovations Inc.'s malaria test, the first of its kind approved in the U.S.

For laboratory use only, the Binax NOW test detects the presence of malaria in a blood sample within 15 minutes. Currently used tests require health professionals to spot malaria parasites under a microscope. Malaria is a mosquito-borne disease that can be fatal if left untreated.

"Since malaria is uncommon in the United States, clinicians and lab personnel may not be accustomed to diagnosing this disease," said Daniel Schultz, director of FDA's device center.

While the results from the Binax must be confirmed by a health care professional, company studies showed the test accurately detected malaria 95 percent of the time

Although malaria has been extremely rare in the U.S. since the 1950s, the disease can still infect U.S. residents who travel abroad. The Centers for Disease Control and Prevention reported more than 1,500 new cases of malaria in 2005.

Shares of Inverness Medical Innovations Inc. rose 79 cents, or 1.57 percent, Tuesday to close at $50.99.