Hologic And Grifols Get FDA Approval For Procleix Zika Virus Assay

Hologic, Inc. HOLX and Grifols GRFS disclosed Monday that the U.S. Food and Drug Administration has approved use of the Procleix Zika virus blood screening assay on the Procleix Panther system under the agency's Investigational New Drug (IND) trial protocol.

According to Hologic and Grifols, prominent U.S. blood centers would use the Procleix Zika virus assay to screen donated blood collected in potential endemic areas of the southern United States, and may extend testing to other regions of the America if the virus continued to spread.

Hologic Division President, Tom West, commented, "Zika virus is a rapidly growing threat to public health. Today's announcement demonstrates our ability to quickly develop molecular diagnostics in response to new and emerging pathogens."

Similarly, Grifols Diagnostic Division'sPresident, Carsten Schroeder, said, "As a global leader in Transfusion Medicine. Grifols is proud to serve blood banks and healthcare professionals working around the world to ensure patients receive safe blood transfusions."