FDA Permits Marketing of First Test to Help Diagnose Dengue Fever

/PRNewswire/ -- The U.S. Food and Drug Administration today 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.

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.

The DENV Detect IgM Capture ELISA test detects antibodies to dengue virus in blood samples from patients who have signs and symptoms of dengue. The test will be available for use in clinical laboratories and will assist in the diagnosis of dengue, which can improve patient care and management.

The DENV Detect IgM Capture ELISA test is based on technology patented by the CDC and manufactured by Seattle-based Inbios Inc.

"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.

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.

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Dengue Fever and Insect-Borne Infections Emerging as Public Health Problem in Areas of the United States

/PRNewswire/ -- Several cases of dengue fever, a potentially fatal viral disease transmitted by the bite of urban dwelling Aedes aegypti and Aedes albopictus mosquitoes, have recently been reported in the continental United States. Prevalent in Central America and the Caribbean, dengue fever's most common symptoms include fever, chills, headache, and body aches lasting several days. The disease's more threatening form, dengue hemorrhagic fever, can cause internal bleeding, loss of blood pressure, and death. Over the past five years, outbreaks of both forms of the disease have been reported in Texas and Florida.

Despite the threat of further introduction of dengue into the mainland United States, as well as the risk of introduction of additional vector-borne diseases, President Obama's 2011 fiscal budget reduces to zero the funding to support the vector-borne infectious disease program at the Centers for Disease Control and Prevention (CDC), the only national program that focuses of detection and outbreak control of vector-borne diseases including dengue, plague, viral encephalitis and Lyme disease.

"At the American Society for Tropical Medicine and Hygiene, we are concerned that the currently proposed 2011 budget would not provide sufficient funding for this important government function. One in fifty people in the world dies of an illness acquired from an insect bite, and tens of thousands of Americans already fall ill each year from infections transmitted by mosquitoes and ticks. Insects do not respect state borders, and neither can our national response," said Edward T. Ryan, M.D., President, American Society of Tropical Medicine and Hygiene (ASTMH). "Although we recognize and applaud the need to constantly scan the Federal budget to identify outdated or unnecessary programs, eliminating the CDC's vector-borne infectious disease program is not one of these areas. The proposed cuts to this program would be shortsighted, and would harm the health of the American people."

Considering dengue as an example, beginning in the 1980s, dengue fever re-emerged as a widespread tropical infection throughout Central America and the Caribbean, pervasive in Cuba, the Dominican Republic, and Puerto Rico. Tens of thousands of cases of dengue and several thousand dengue hemorrhagic fever cases occur annually across Central America and the Caribbean. The disease's reach is not limited to these regions, however. In 2005, dengue fever emerged in Brownsville, TX and in 2009, the disease returned to the Florida Keys, after a 75-year hiatus. These recent outbreaks of dengue and dengue hemorrhagic fever suggest that the disease could spread and become a health threat in major Gulf Coast cities such as Corpus Christi, Houston, New Orleans, Biloxi, Mobile, Pensacola and Tampa, as well as in less populated areas.

The World Health Organization estimates that 2.5 billion people (two fifths the world's population), risk contracting dengue, and that there may be as many as 50 million cases of dengue fever every year. The disease disproportionately affects poor populations, whose low-quality living conditions and link to poor sanitation are conducive to the establishment of mosquito breeding sites, and increase this demographics' contact with Aedes mosquitoes. Currently, there is no vaccine approved to protect humans against dengue, and the most effective protective measures are those to avoid mosquito bites (wearing bug repellent, spraying pesticides, and dumping any standing water). If infected, the early recognition and prompt treatment can help lower the risk of developing severe disease complications.

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