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FDA Approves Use of the Procleix Zika Virus Assay from Hologic and Grifols to Screen the U.S. Blood Supply Under an IND Study Protocol

Hologic, Inc.

Blood banks will use the new test to screen donated blood in potential endemic areas of the US

9 Aug 2016
Alex Waite
Editorial Assistant

Product news

Hologic, Inc. and Grifols – market-leading partners committed to blood safety – has announced that the U.S. Food and Drug Administration (FDA) has approved use of the Procleix Zika virus blood screening assay on the Procleix Panther system under the agency's Investigational New Drug (IND) study protocol.

Prominent U.S. blood centers will use the Procleix Zika virus assay to screen donated blood collected in potential endemic areas of the southern U.S., and may expand testing to other areas of the U.S. if the virus continues to spread.

"The American Red Cross is pleased to participate in the Procleix Zika Virus assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus," said Susan Stramer, Ph.D., Vice President of Scientific Affairs at the American Red Cross. "Working together, we remain committed to ensuring the safety and availability of the U.S. blood supply for patients in need."

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

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

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FDA Approves Use of the Procleix Zika Virus Assay from Hologic and Grifols to Screen the U.S. Blood Supply Under an IND Study Protocol