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Grifols' blood test for Zika virus detection wins US FDA approval

Grifols SA won U.S. Food and Drug Administration approval for its test to detect the Zika virus in plasma specimens from human donors who provide whole blood and blood components for transfusion.

The test, called the Procleix Zika virus assay, is also approved to screen plasma or serum specimens from other living or cadaver organ donors, as well as human cells, tissues and cellular and tissue-based products, the Barcelona-based company said in an Aug. 14 statement.

Blood banks and donor centers can use the test to help determine the safety of their blood supplies, Grifols said.

The Procleix Zika virus assay was first used under an investigational new drug protocol in the U.S. in June 2016.

Grifols said the Zika assay project received funding from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response and Biomedical Advanced Research and Development Authority.

Zika virus is spread mainly by the bite of an infected mosquito of the Aedes genus, which bites during the day and night. An infected pregnant woman may pass the virus to her fetus, which can lead to certain birth defects. There is currently no available vaccine or medicine for Zika.