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FDA Clears CDC's Dengue MDx Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing a test for dengue virus developed by the US Centers for Disease Control and Prevention, CDC said today.

The test is the first FDA-approved molecular test for dengue and uses real-time PCR technology. Called the CDC DENV-1-4 Real Time RT PCR Assay, it can detect dengue within the first seven days after symptoms appear and can detect all four dengue virus types, CDC said.

Other available FDA-approved tests for dengue use antibody-based methods for detection of the virus. While most patients develop these antibodies four days after becoming ill, some do not develop them until seven days after becoming ill. As a result, an antibody-based test may not detect the virus early on.

"The need for a new dengue diagnostic test was high," Jorge Munoz-Jordan, chief of molecular diagnostics and research at the CDC Dengue Branch, said in a statement. "Patients will be diagnosed sooner than before, and public health laboratories will have a clearer picture of the true number of dengue cases. Dengue is now a reportable disease in the United States, and the availability of state-of-the-art dengue diagnostics will improve patient management and the public health response to dengue."

The test can be done using equipment and supplies that many public health laboratories already use for the diagnosis of influenza. Facilities in the US and internationally that run the commonly used influenza Real-Time PCR assays, developed also by CDC, can run the dengue assay.

Test kits will be distributed starting July 2, CDC said.