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Grifols’ Zika Test Available for Blood Screening in Europe

By Barry Teater, NCBiotech Writer

A test for screening blood donations for presence of the Zika virus is now being sold in Europe by Grifols, a global developer of plasma-derived medicines that has 2,500 employees in North Carolina.

The test will allow blood banks and donor centers to protect the safety of their blood supplies from Zika, a mosquito-borne virus that can cause congenital brain abnormalities, including microcephaly, in babies born to women who are infected while pregnant.

Grifols said in a news release that the test can be used in countries that accept the CE Mark, a company’s declaration that their product complies with relevant European health, safety and environmental protection legislation.

Grifols tests for Zika with this Procleix Panther system, a screening platform using nucleic acid testing for fully automated blood testing. -- Grifols photo

The test is designed to be used with the Procleix Panther system, a screening platform that uses nucleic acid testing for fully automated blood testing.

“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 Carsten Schroeder, president of Grifols’ diagnostic division.

Procleix systems are used to screen blood donations around the world for HIV, hepatitis, West Nile virus and more. Procleix has received regulatory approvals in several countries and is in development for the U.S. market.

The Zika assay is currently being used in the United States under an Investigational New Drug protocol in response to the Food and Drug Administration’s recommendation to screen all U.S. blood donations for Zika virus.

The assay was developed at Grifols’ diagnostic division in Los Angeles but has marketing, communications and finance support from the company’s corporate office in the Research Triangle Park, said Anna Gurney, corporate communications manager in RTP.

Grifols Growing in NC

Grifols, headquartered in Barcelona, Spain, has about 15,000 employees in more than 100 countries. It offers a comprehensive range of transfusion medicine, hemostasis and immunoassay solutions for clinical laboratories, blood banks and transfusion centers. It has about 170 plasma-donation centers in the U.S.

In 2011 Grifols completed a $3.4 billion acquisition of Talecris Biotherapeutics including a corporate headquarters in RTP and a production campus in Clayton.

Grifols expanded the Clayton site with a new $370 million plasma fractionation plant, completed in 2014.

The company announced in March 2016 it would invest another $210 million in two new plants at the site: a $90 million plasma fractionation plant and a $120 million purification plant for intravenous immunoglobulin.

The plasma fractionation plant is scheduled to start production in 2022. It will extract proteins used to treat rare and chronic diseases such as immune deficiencies, hemophilia, genetic emphysema and neurological disease.

The purification plant is scheduled to begin production in late 2021. It will purify immunoglobulin for use in treating several diseases of the immune system and other disorders.

The Clayton campus employs about 1,600 people, making it the largest employer in Johnston County. The RTP facility employs about 400, and about 500 work at plasma-donation centers throughout North Carolina.

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