FDA Approves Use of New Zika Assay to Screen Blood Supply

The US Food & Drug Administration (FDA) has approved the use of a new Zika virus assay to screen the USA blood supply under its Investigational New Drug (IND) study protocol. Blood banks will use the test on an automated nucleic acids technology (NAT) platform to screen donated blood in potential endemic areas.

The Procleix Zika virus assay, co-developed by leading blood safety partners Hologic, Inc. (Marlborough, MA, USA) and Grifols (Emeryville, CA, USA), will be used on the automated Procleix Panther system. Procleix Panther automates all aspects of NAT-based blood screening on a single, integrated platform. It eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use. The system has received regulatory approvals in countries around the world, and is in development for use in the US.


Prominent blood centers will use the assay to screen donated blood collected in potential endemic areas of the southern US, 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, PhD, vice president, Scientific Affairs, American Red Cross, "Working together, we remain committed to ensuring the safety and availability of the US blood supply for patients in need."

"Zika virus is a rapidly growing threat to public health," said Tom West, division president, Diagnostic Solutions, Hologic, the “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, 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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