Roche’s cobas Zika test has won FDA approval for use in screening blood donations. The nod from the FDA clears all blood collection establishments to follow its guidance and test for the virus.
Final FDA guidance published last year recommended all states and territories test whole blood and blood components for Zika virus. However, until now, such tests were classed as experimental and only available under investigational new drug (IND) applications. The FDA said “several” blood collection establishments used Roche’s Zika test under the IND.
Data from those establishments and studies performed by Roche have opened the door to more widespread use of the test, which runs on the Swiss company’s cobas 6800 and 8800 systems. The qualitative in vitro nucleic acid screening test is designed to detect Zika virus RNA. Like other tests that run on the cobas 6800 and 8800 systems, the Zika screen benefits from automated sample preparation. The technology carries out the nucleic acid extraction and purification.
Roche’s test achieved clinical specificity of 99% when individual samples from blood donations were tested at five external laboratories. The results convinced the FDA the cobas test is effective at screening blood donors for infection with the virus. And, in doing so, brought the Zika test’s 18-month journey from IND to approval to an end.
“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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The approval adds to the arsenal of tests available to stop the spread of Zika virus, most notably by providing blood collection establishments with a FDA-cleared screen for the first time. Other tests, such as those from Abbott and Siemens, have received clearance for use in emergencies. Abbott broke new ground in February when the FDA expanded its clearance to cover whole blood, not just serum plasma and urine.