FDA announces availability of new Zika screening test

The U.S. Food and Drug Administration announced on Wednesday that a new investigational test to screen blood donations for Zika virus is now available in areas with known mosquito-borne transmission of Zika.

“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those U.S. territories already experiencing active transmission,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said. “In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”

The FDA recommends that areas with active transmission of Zika virus obtain whole blood and other blood components from areas without active transmission of Zika virus. With the new test, manufactured by Roche Molecular Systems, Inc., areas with known transmission will be able to begin accepting donations again.

“The close collaboration between the FDA and the product manufacturer was essential to expediting availability of this investigational test,” Luciana Borio, the FDA’s acting chief scientist, said. “This type of cooperation, which is typical of the FDA and its U.S. government partners during all public health emergencies, requires a tremendous agency effort and underscores the importance of having adequate resources available to support essential Zika virus response activities.”