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Dx Focus: CDC's Dengue Fever Assay; Asuragen Grants BD License to Armored RNA Tech


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 this week.

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

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

The assay can be performed using equipment and supplies that many public health laboratories already use to diagnose influenza, CDC said. Facilities in the US and internationally that run the commonly used influenza real-time PCR assays developed by CDC can also run the dengue assay.

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

Asuragen said this week that it has granted Becton Dickinson the rights to use its Armored RNA technology in BD Diagnostic's in vitro molecular diagnostic products.

Under the terms of the non-exclusive worldwide agreement, Asuragen will develop and supply reagents for BD in its cGMP manufacturing facility. Additional details were not disclosed.

Asuragen and Cenetron Diagnostics jointly invented and developed the Armored RNA technology to create RNA and DNA standards for molecular diagnostic assays. The technology encapsulates RNA standards in a protective protein coat, assuring their integrity during long-term storage and "armoring" the RNA standard against the hazards of nucleases in patient samples.

Austin, Texas-based Asuragen said that the technology has been incorporated into most HIV and HCV commercially available diagnostic assays that measure viral load.

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