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FDA approves Grifols’ blood screening assay for Zika virus
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Grifols announced that the FDA has approved its Procleix assay for the detection of Zika virus in the U.S. blood supply.
The assay has been approved for use in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion, and for testing plasma or serum specimens to screen other living or cadaveric organ donors and human cells, tissues and cellular and tissue-based products, Grifols said in a news release.
Procleix had already been in use since June 2016 to screen the U.S. blood supply for Zika under an FDA-approved investigational new drug protocol.
“This approval marks yet another milestone for [the] Grifols diagnostic division, and continues to strengthen our leadership position in [nucleic acid technology] blood screening safety," Carsten Schroeder, president of diagnostic commercial operations at Grifols, said in a news release. "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.”
The FDA recently announced that the U.S. would no longer screen individual blood donations for the presence of Zika virus unless a localized risk warranted such testing. Blood establishments will continue screening pooled donations for the virus, which can cause severe health problems in infants born to infected mothers.
The updated FDA guidance came on the heels of a report that questioned the value of individual screening.
Disclosure: Schroeder works for Grifols.