FDA Clears First Zika Assay for Blood Supply
The FDA approved the first Zika virus detection test for screening blood donations.
The cobas Zika test, manufactured by Roche Molecular Systems, was approved last year for individual diagnoses of Zika virus infection under investigational new drug applications after the FDA issued final guidance in August 2016 on screening individual blood units for Zika virus.
Primarily transmitted by the Aedes aegypti mosquito, Zika virus can spread via a blood transfusion. The newly approved assay for the cobas 68000 and 8800 systems has helped to identify and remove more than 450 potentially infectious donations from the blood supply, according to Roche Diagnostics CEO Roland Diggelmann.