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FDA Permits Marketing of First Test to Help Diagnose Dengue Fever
Date:4/8/2011

will now aid health care professionals in their effort to more effectively diagnose dengue."

The FDA reviewed data for the test via the "de novo" pathway, an alternative path to market for devices that are low to moderate risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a "510(k)" premarket notification.

People who believe they have dengue should immediately contact a health care professional. There are no FDA-licensed vaccines to prevent dengue and no medicines specifically approved to treat the infection.

The test should not be used in people who do not show signs or symptoms of dengue. Diagnostic testing for dengue is complicated by the fact that an IgM antibody response to the dengue virus infection is not detectable until 3-5 days after the onset of fever, which can produce a negative test result even though a person has dengue. During this "IgM negative window" the dengue virus is present in the bloodstream.

There are currently no FDA-cleared or approved tests for direct detection of dengue virus.

This new test shows cross-reaction with other closely related viruses such as those that cause West Nile disease. However, in most patient testing situations found in the United States, a positive test result in a patient with signs or symptoms consistent with dengue should be considered presumptive evidence of dengue.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Evaluation of Automatic Class III Designation (De Novo) Decision Summaries

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm232269.htm

CDC: Dengue

http://www.cdc.gov/dengue/

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SOURCE U.S. Food and Drug Administration
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