FDA Approves First Zika Test for Blood Donations

Oct 06, 2017

The FDA announced it has approved the first test intended for use by blood collection establishments to detect Zika virus in blood donations.

The cobas Zika test, made by Roche Molecular Systems, is a qualitative nucleic acid test that detects Zika virus RNA in plasma specimens taken from donated whole blood and blood components as well as living organ donors.

“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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Headquartered in Pleasanton, California, Roche Molecular Systems is a business area of Roche Diagnostics that develops, manufactures and supplies an array of medical diagnostic products, services, tests, platforms and technologies.

Read the FDA press release