Procleix® Zika Virus Assay Approved by the FDA for Blood Screening on the Procleix® Panther® System
- Procleix Zika Virus assay approved for the detection of viral RNA in plasma and serum specimens, previously used since June 2016 under IND protocol.
- Procleix Zika Virus assay provides U.S. blood banks the ability to screen blood donations for the presence of the Zika virus and improve blood transfusion safety.
- Through continuous innovation, three additional products have been approved with more under development for the Procleix Panther System, broadening the portfolio to improve blood safety worldwide.
Barcelona, August 14, 2018 - Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading 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.
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.