Oct. 10, 2017—The U.S. Food and Drug Administration approved on Oct. 5 Roche’s Cobas Zika test for use on the company’s fully automated Cobas 6800/8800 systems. The test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from volunteer donors of whole blood and blood components and from living organ donors. It is intended for use by blood collection sites to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
Roche deployed the test in April 2016 under the FDA’s investigational new drug protocol to screen blood donations collected in Puerto Rico.