Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays

Grifols announced that it has received approval from the U.S. Food & Drug Administration (FDA) for two blood screening assays: Procleix Ultrio Elite and Procleix WNV. Procleix Ultrio Elite is an assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) as well as detecting HIV type 2 (HIV-2). The Procleix Ultrio Elite assay can be used to test pools of plasma composed of up to 96 individual donations from donors of source plasma. Procleix WNV assay is a highly sensitive, qualitative in vitro nucleic acid assay for the detection of West Nile virus RNA in plasma and serum of human blood donors.

“These FDA approvals demonstrate our ongoing commitment to expand Grifols comprehensive Nucleic Acid Testing (NAT) solutions portfolio to help labs administer NAT,” said Carsten Schroeder, President, Grifols Diagnostic Division. “The addition of the Procleix Panther system with these assays will allow blood centers to efficiently screen for infectious diseases on one simple, automated platform while adapting to changes in donation volume and regulatory requirements.”

Both assays will run on the fully automated NAT blood screening platform Procleix Panther system. The device is an integrated nucleic acid testing system that fully automates all necessary steps to perform Procleix assays, from sample processing through amplification, detection, and data reduction. The Procleix Panther system was created to be a fully automated sample-to-result instrument that eliminates the need for batch processing.

Grifols will begin commercializing the Procleix Ultrio Elite and Procleix WNV assays in the U.S. later this year.

The Procleix Panther system received CE Mark and launched in Europe in 2012. In June 2016, the FDA allowed blood centers the use of Grifols Procleix Zika virus assay with the Procleix Panther system, under an Investigational New Drug study protocol, to screen donated blood nationwide.