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Grifols Gets FDA Clearance for Two Blood Screening Assays on Procleix Panther System

NEW YORK (GenomeWeb) – Two new blood screening assays developed by Grifols have been cleared by the US Food and Drug Administration, the firm announced today.

The Procleix Ultrio Elite is a combined screening test for the HIV-1, hepatitis B, and hepatitis C viruses, and also enables detection of HIV-2. It can be used to test pools of plasma composed of up to 96 plasma donor samples. The Procleix WNV test screens serum and plasma donations for West Nile virus. The tests run on Grifols' Procleix Panther system.

The Procleix Panther nucleic acid test (NAT) blood screening platform is a fully automated sample-to-result instrument that can eliminate the need for batch processing, Grifols said in a statement. 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 study protocol to screen donated blood nationwide. The firm has since launched an IND Babesia screening test on the platform.

"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," Carsten Schroeder, the president of Grifols' diagnostic division, said in a statement.

The firm said it will begin commercializing the Procleix Ultrio Elite and Procleix WNV assays in the US later this year.