Grifols, one of the world’s leading producers of plasma-derived medicines, 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 U.S., the assay is currently being used under an Investigational New Drug (IND) protocol in response to the U.S. 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.
About Procleix NAT Solutions
The Grifols Procleix portfolio of nucleic acid testing (NAT) products are developed as part of a long-standing partnership between Hologic and Grifols. Today, Procleix systems are used to screen more blood donations around the world than any other NAT blood screening products, and include tests for HIV, hepatitis, West Nile virus and more.
The Procleix Panther system 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 the U.S. market.
About Zika Virus
According to the World Health Organization, Zika virus is an emerging mosquito-borne virus that was first identified in rhesus monkeys in Uganda in 1947 and in humans in 1952. Outbreaks of the Zika virus disease have been recorded in Africa, the Americas, Asia and the Pacific. Zika virus is transmitted to people primarily through the bite of an infected mosquito from the Aedes genus, mainly Aedes aegypti, in tropical regions. This is the same mosquito that transmits dengue, chikungunya and yellow fever. However, sexual transmission of Zika virus is also possible. Other modes of transmission such as blood transfusion and perinatal transmission are currently being investigated. In total, 64 countries and territories have reported transmission of Zika virus since January 1, 2007.
According to the U.S. Centers for Disease Control and Prevention, local mosquito-borne Zika virus infections have been detected in Florida and Texas, and in US Territories there are reports in the Commonwealth of Puerto Rico, the U.S. Virgin Islands, and American Samoa.