Navigation Links
FDA Permits Marketing of First Test to Help Diagnose Dengue Fever

SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ -- 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.

For more information:

FDA: Medical Devices

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

CDC: Dengue

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988,
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vystar® Corporation Appoints Joanne Kearney as Vice President of Marketing
2. SinoFresh HealthCare Signs Three Sale Marketing Agreements
3. Cynosure Receives International Marketing Clearances for New Cellulite, Laser Lipolysis Products
4. Streamline Health Appoints Rick Leach as Senior Vice President and Chief Marketing Officer
5. ViewRay Receives FDA 510(k) Marketing Clearance for Treatment Planning and Delivery Software
6. Caliper and Covaris Establish Co-Marketing Agreement to Simplify Next Generation Sequencing
7. Behavioral Marketing Goes Mobile
8. Thought Leader Select Announces Media Partnership with Marketing4Health
9. Simcere Pharmaceutical Group Appoints Industry Veteran Mr. Hong Zhao as Executive Vice President of Sales and Marketing
10. Peter Dannenfelser Joins Targetbase as Vice President of Strategy, Bringing 15 Years of Pharmaceutical Marketing Experience
11. Thats Nice LLC Launches Nice Insight Marketing Intelligence for CRAMs With Its Pharma & Biotech Outsourcing Survey
Post Your Comments:
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
(Date:11/25/2015)...  Today AVACEN Medical announced the issue of United States patent No. ... ". This patent shields the company,s AVACEN 100 dry heat therapy medical device and specific methods ... Photo - ... ... ...
(Date:11/25/2015)... , Nov. 25, 2015 USP 800 ... drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, ... technicians). The chapter also covers all entities which ... pharmacies, hospitals, other healthcare institutions, patient treatment clinics, ... --> --> What is ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug rehabilitation ... new cutting edge recovery program that has been 50 years in the making. ... with the purpose to free addicts from the symptoms and negative behaviors of addiction. ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for ... aware of the benefits of Botox® in the treatment of moderate facial wrinkling, few ... and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted by an ... IL, UV Angel is evaluating the efficacy of its product and its disinfection protocol. ... 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical ...
(Date:11/25/2015)... Spring, Md (PRWEB) , ... November 25, 2015 ... ... Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible ... history of this disease. The Periwinkle Pioneers, nominated by the public, will receive ...
Breaking Medicine News(10 mins):