The test is designed to be used by blood collection establishments to detect Zika virus in blood donations – not for the diagnosis of Zika virus infection in an individual.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in prepared remarks.
“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. 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.”
Last year, the FDA issued guidance recommending that states and territories screen individual units of blood with an investigational test or a licensed test as soon as it was available.
Before this approval, several blood collection establishments were using Roche’s cobas Zika test under IND and the data collected during that time, as well as from additional studies done by Roche, showed that the test is an effective way to screen blood donors for Zika virus infection.
Although the Zika virus is primarily transmitted by mosquitoes, it can also be spread among people through blood transfusion.