FDA approves Procleix Zika Virus assay for detection of Zika virus.- Grifols.
Grifols announced that the 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.
Comment: 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.
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