FDA Approves First Zika Screening Test

The U.S. Food and Drug Administration (FDA) approved the cobas Zika test, the first test for screening the nation’s blood supply and organ donations for the Zika virus. The cobas Zika test is a qualitative nucleic acid test that can be used in individual plasma specimens obtained from volunteer donors of whole blood and blood components, as well as from living organ donors.

“Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”

In August 2016, the FDA issued a final guidance document recommending that states and territories screen blood donations for the Zika virus using a screening test under an investigational new drug (IND) application or an approved test when available. Prior to this approval, several blood-collection establishments used the cobas test under IND; collected data demonstrated its efficacy in detecting the virus.

In its approval notice, the FDA stated that the test is intended for use on the fully automated cobas 6800 and cobas 8800 systems by blood-collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.

Source: FDA press release, October 5, 2017.