Two Viral Blood Screening Assays Get FDA Clearance

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A global producer of plasma-derived medicines and a developer of diagnostic solutions announced today that it has received approval from the U.S. Food & Drug Administration (FDA, Silver Springs, MD, USA) for two blood screening assays.

One 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.

Both assays will run on the fully automated nucleic acid testing (NAT) blood screening platform Grifols’ 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 USA later this year.

The system received CE marking and launched in Europe in 2012 and in 2016, the FDA allowed blood centers to use the Grifols’ Procleix Zika virus assay with the Procleix Panther system under an Investigational New Drug (IND) study protocol to screen donated blood nationwide. The firm has since launched an IND Babesia screening test on the platform.

Carsten Schroeder, BA, MBA, the president of Grifols' diagnostic division, said, “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.”

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U.S. Food & Drug Administration