Photo courtesy of UAB Hospital
The US Food and Drug Administration (FDA) has approved the use of a new assay to screen donated blood for the Zika virus.
The Procleix Zika Virus Assay is approved for use under an investigational new drug study protocol.
Blood banks can use the test to screen donated blood for the Zika virus in potentially endemic areas of the southern US. Testing may be extended to other areas of the US if the Zika virus continues to spread.
The Procleix Zika Virus Assay, which was co-developed by Hologic, Inc. and Grifols, is designed to run on the Procleix Panther System, an automated, nucleic acid technology blood screening platform. The system has received regulatory approvals in countries around the world and is currently in development for the US market.
“The American Red Cross is pleased to participate in the Procleix Zika Virus Assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus,” said Susan Stramer, PhD, vice-president of scientific affairs at the American Red Cross.
The FDA previously authorized use of another test, the cobas® Zika test (developed by Roche), to screen blood donations for Zika virus. The cobas Zika test can be used under an investigational new drug study protocol for screening donated blood in areas with active, mosquito-borne transmission of the Zika virus.
