Skip to main content

FDA Approves Roche Zika Virus Assay for Blood Donation Screening

NEW YORK (GenomeWeb) – The US Food and Drug Administration on Thursday announced that it has approved Roche's Cobas Zika test for detecting the virus in blood donations.

The qualitative in vitro nucleic acid screening test is designed to directly detect Zika virus in plasma specimens from individual human blood donors and living organ donors. It runs on Roche's fully automated Cobas 6800/8800 systems. The FDA noted that the test is intended for use by blood collection facilities and is not approved for the individual diagnosis of Zika infection.

The FDA's action represents the first time a Zika virus detection test has been approved for use in screening blood supplies, Center for Biologics Evaluation and Research Director Peter Marks said in a statement. "Screening blood donations for the Zika virus is critical to preventing infected donations from entering the US blood supply," he added.

In early 2016, Roche began using the Zika assay to screen blood samples under an Investigational New Drug application protocol. The FDA said that the company generated data using individual blood donation samples from five external laboratory sites that showed the test could effectively screen for Zika infection with clinical specificity of greater than 99 percent.