Dengue fever test wins FDA nod

The U.S. Food and Drug Administration (FDA) has approved the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever.

Manufactured by Seattle-based Inbios Inc., the DENV Detect IgM Capture ELISA test detects antibodies to dengue virus in blood samples from patients who have signs and symptoms of dengue.

According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 100 million people worldwide are infected by the virus each year. The dengue virus is transmitted to humans by the bite of an infected Aedes mosquito.

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.

Most reported dengue cases in the continental United States occur in people returning from travels to tourist destinations in Latin America, the Caribbean and Southeast Asia. Dengue is also endemic in the U.S. in Puerto Rico, the Virgin Islands and some U.S.-affiliated Pacific Islands. Recently, dengue outbreaks have occurred in Hawaii, Texas, and Florida.

“Cases of dengue fever or dengue hemorrhagic fever can be potentially fatal for people who do not recognize the symptoms,” said Alberto Gutierrez 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 US health regulator said it 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.