FDA Approves Grifols’ Procleix Zika Virus Assay

Grifols, a global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced that the U.S. Food and Drug Administration (FDA) approved the Procleix Zika Virus assay for the detection of 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.
 
“This approval marks yet another milestone for Grifols Diagnostic Division, and continues to strengthen our leadership position in NAT blood screening safety,” said Carsten Schroeder, president, Grifols Diagnostic Commercial Operations. “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.