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Grifols Gets FDA Clearance for Procleix Zika Virus Assay

NEW YORK (GenomeWeb) – Grifols said today that its blood screening assay to detect Zika virus has been cleared by the US Food and Drug Administration.

The Procleix Zika Virus assay — which was previously available under an investigational new drug protocol — is now approved to detect Zika virus RNA in individual or pooled plasma specimens from blood donors, as well as specimens from organ donors, human cells, tissues, and cellular and tissue-based products. The assay runs on the Procleix Panther automated system. It received Emergency Use Authorization as well as IND and CE marking in 2016, before the Barcelona-based firm was divested from Hologic.

"This approval marks yet another milestone for Grifols' Diagnostic Division and continues to strengthen our leadership position in [nucleic acid technology] blood screening safety," Carsten Schroeder, president of Grifols' diagnostic commercial operations, said in a statement. "With more assays currently under development, our teams will relentlessly continue to address any threat to the blood supply and support our mission to improve patients' well-being and blood safety worldwide."

Grifols recently received FDA clearance for its West Nile Virus assay as well as its Procleix Ultrio Elite test, which screens for HIV-1, HCV, and HBV, and detects HIV-2.

An evaluation by Grifols, the American Red Cross, and others published last year found that testing individual donated blood samples for Zika virus is costly and has low yield. Last month the FDA revised previous guidelines for Zika testing of blood products, and now recommends pooled testing.

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