First Quick Test for Malaria: FDA-Cleared for Marketing

Filed in archive Diagnostics , News on July 3, 2007

Intended for laboratory use only, Binax NOW Malaria Test - the first authorized U.S. rapid test for malaria - has now been cleared by the US FDA for marketing.

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.

A mosquito-borne disease caused by a parasite - malaria - is just being identified in the lab by looking under the microscope and identifying the parasites in the blood sample.

Manufactured by Binax, Inc. (a subsidiary of Inverness Medical Innovations Inc.), the Binax NOW Malaria Test has proved 95% more accurate than the standard microscopic diagnosis.

Read the full FDA report.