The FDA has allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever.
The U.S. Food and Drug Administration last week allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.
The dengue virus is transmitted to humans by the bite of an infected Aedes mosquito. As many as 100 million people worldwide are infected by the virus each year, according to the U.S. Centers for Disease Control and Prevention (CDC).
Symptoms of dengue fever include high fever, severe headache, severe pain behind the eyes, joint pain, muscle and bone pain, rash and mild bleeding involving the nose or gums, and easy bruising.
"Cases of dengue fever or dengue hemorrhagic fever can be potentially fatal for people who do not recognize the symptoms," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics Device Evaluation and Safety in FDA's Center for Devices and Radiological Health. "This test 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.
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.
