FDA has approved use of the Procleix Zika virus blood screening assay codeveloped by Grifols, Emeryville, Calif, and Hologic Inc, Marlborough, Mass, on the Procleix Panther system, under an investigational new drug study protocol.
Blood centers will use the Procleix Zika virus assay to screen donated blood collected in potential endemic areas of the southern United States, and may expand testing to other areas of the country if the virus continues to spread.
“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,” says Susan Stramer, PhD, vice president of scientific affairs at the American Red Cross. “Working together, we remain committed to ensuring the safety and availability of the US blood supply for patients in need.”
The Grifols Procleix portfolio of nucleic acid technology products was developed as part of a long-standing partnership between Hologic and Grifols. Procleix systems are used to screen blood donations around the world, and include tests for human immunodeficiency virus, hepatitis, West Nile virus, and more.
The Procleix Panther system automates all aspects of nucleic acid-based blood screening on a single, integrated platform. It eliminates the need for batch processing and combines walkaway freedom with intuitive design for ease of use. The system has received regulatory approvals in countries around the world, and is in development for the US market.
“Zika virus is a rapidly growing threat to public health,” says Tom West, president of the diagnostic solutions division at Hologic. “[The recent] announcement demonstrates our ability to quickly develop molecular diagnostics in response to new and emerging pathogens.”
“As a global leader in transfusion medicine, Grifols is proud to serve blood banks and healthcare professionals working around the world to ensure patients receive safe blood transfusions,” says Carsten Schroeder, president of the Grifols diagnostic division.