The test, manufactured by Roche Molecular Systems, is intended to screen for Zika virus in the nation’s blood supply, not for individual diagnosis of infection.
The cobas Zika test can detect the virus’ RNA in plasma taken from whole blood and blood components.
“Today’s approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis and ensure the safety of blood in the U.S. and its territories,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
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