Grifols has secured approval from the US Food and Drug Administration (FDA) for the Procleix® Zika Virus assay to detect the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion.
The Zika Virus assay is also approved for testing plasma or serum specimens to screen other living (heart-beating) or cadaveric (non-heart beating) organ donors and Human Cells, Tissues, and Cellular and Tissue-Based Products.
The Procleix Zika Virus assay has been in use since June 2016 under an Investigational New Drug protocol to screen donated blood collected in the U.S. In 2016 the assay was CE-marked for use in European countries conforming to CE Mark regulations.
The assay is performed on the Procleix Panther system automated platform using nucleic acid technology (NAT), and enables blood banks and donor centers to enhance the safety of their blood supplies.
Grifols Diagnostic Commercial Operations president Carsten Schroeder said: “This approval marks yet another milestone for Grifols Diagnostic Division, and continues to strengthen our leadership position in NAT blood screening safety.
“With more assays currently under development, our teams will relentlessly continue to address any threat to the blood supply, and support our mission to improve patients’ well-being and blood safety worldwide.”
The Zika assay project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600024C.
Grifols recently received FDA approval for two other assays on the Procleix Panther System – the Procleix Ultrio Elite (to screen for HIV-1, HCV, and HBV and detect HIV-2), and West Nile Virus assays.
Company: Press Release.