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
"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.