Zika Virus assay for screening blood donations

Grifols now provides European countries accepting products with the CE marking with a test to detect the presence of the Zika virus in donated blood.

CE marking means a product conforms to relevant legislation for sale in the European economic area. The test is conducted using nucleic acid testing (NAT) on the Procleix Panther system automated platform and enables blood banks and donor centers to enhance the safety of their blood supplies.

In the US, the assay is currently being used under an Investigational New Drug (IND) protocol in response to the US Food and Drug Administration’s recommendation to screen all U.S. blood donations for Zika virus. Hologic, a developer, manufacturer and supplier of diagnostic products, received acknowledgement from the FDA for the assay under an IND status in June 2016.

In January 2017, Grifols acquired Hologic’s business unit engaged in research, development and manufacture of assays and instruments based on NAT technology for blood screening, and became the only vertically integrated provider capable of offering comprehensive solutions to blood and plasma donation centers. This transaction is part of the growth strategy envisaged for the Diagnostic Division and enables Grifols to strengthen its leading position in NAT blood screening safety.

"The CE marking of the Procleix Zika virus assay is a further step in our mission to support safer blood donations, the result of our passion for innovation and the role we play as market leaders in transfusion medicine," said Grifols Diagnostic Division President, Carsten Schroeder.

NAT offers the capacity to detect the presence of infectious agents in blood and plasma donations, and contributes to increase safety in transfusion diagnostics.