CDC and the Diagnostics Industry Continue to Battle Zika

While summer has ended, the battle against the mosquito-borne virus Zika continues. On Oct. 21, the Centers for Disease Control and Prevention (CDC) announced approximately $70 million will be made available to state and local agencies to fight Zika. The funding comes through the agency's Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement and will be used for surveillance and investigation, mosquito control and laboratory capacity. The CDC has also updated prior travel and testing guidance on Zika transmission to cover all of Miami-Dade County in Florida, as mosquito transmission of the virus continues to be reported in that region. The number of locally acquired cases of the virus is low in the United States at 137 according to the CDC's Oct. 19 update, but there are a total of 4,016 cases in the U.S. with 3,878 related to travel. One reported case was laboratory-acquired.

While locally mosquito-transmitted cases in the United States have only occurred to date in Florida, travel related cases have been reported in all 50 states with the most occurring in California, Florida and New York. Just as virus transmission has not abated, efforts to develop better diagnostics continue in earnest. The FDA has issued a total of 12 Emergency Use Authorizations for the following in-vitro diagnostics.

• Zika Virus Detection by RT-PCR Test (ARUP Laboratories)

• Sentosa® SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)

• LightMix® Zika rRT-PCR Test (Roche Molecular Systems, Inc.)

• ZIKV Detect™ IgM Capture ELISA (inBios International, Inc.)

• xMAP® MultiFLEX™ Zika RNA Assay (Luminex Corporation)

• VERSANT® Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)

• Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test

• Aptima® Zika Virus Assay (Hologic, Inc.)

• RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics)

• Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics)

• Zika MAC-ELISA (CDC)

• Trioplex Real-time RT-PCR Assay (CDC)

Takeaway: While locally transmitted cases of Zika virus are limited so far to Florida, travel related cases continue to rise and the diagnostics sector continues to seek ways to improve virus detection.