Procleix® Zika Virus Assay Approved by the FDA for Blood Screening on the Procleix® Panther® System
BARCELONA, Spain, Aug. 14, 2018
BARCELONA, Spain, Aug. 14, 2018 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced that the U.S. Food and Drug Administration (FDA) approved the Procleix® Zika Virus assay for the detection of the virus in individual or pooled plasma specimens from human donors, including volunteer donors of whole blood and blood components for transfusion. The Zika Virus assay is also approved for testing plasma or serum specimens to screen other living (heart-beating) or cadaveric (non-heart beating) organ donors and Human Cells, Tissues, and Cellular and Tissue-Based Products.
The Procleix Zika Virus assay has been in use since June 2016 under an Investigational New Drug protocol to screen donated blood collected in the U.S. In 2016 the assay was CE-marked for use in European countries conforming to CE Mark regulations. The assay is performed on the Procleix® Panther® system automated platform using nucleic acid technology (NAT), and enables blood banks and donor centers to enhance the safety of their blood supplies.
"This approval marks yet another milestone for Grifols Diagnostic Division, and continues to strengthen our leadership position in NAT blood screening safety," said Carsten Schroeder, President, Grifols Diagnostic Commercial Operations. "With more assays currently under development, our teams will relentlessly continue to address any threat to the blood supply, and support our mission to improve patients' well-being and blood safety worldwide."
The Zika assay project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600024C.
Grifols recently received FDA approval for two other assays on the Procleix Panther System - the Procleix Ultrio Elite (to screen for HIV-1, HCV, and HBV and detect HIV-2), and West Nile Virus assays.
According to the World Health Organization, the 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 perinatal and blood transfusion have also been documented. There is now a scientific consensus that Zika virus can cause microcephaly in children born to women infected with the virus during pregnancy and can also be a cause of Guillain-Barré syndrome in the general population.
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 U.S. Territories of Puerto Rico, the U.S. Virgin Islands, and American Samoa.
About Procleix NAT Solutions
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 viruses (A, B, C and E), West Nile virus, Zika virus, dengue 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, including the U.S.
Grifols is a global healthcare company with more than 75 years of legacy dedicated to improving the health and well-being of people around the world. Grifols produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to help them deliver expert medical care.
Grifols' three main divisions – Bioscience, Diagnostic and Hospital – develop, produce and market innovative products and services that are available in more than 100 countries.
With a network of 225 plasma donation centers, Grifols is a leading producer of plasma-derived medicines used to treat rare, chronic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of diagnostic products designed to support safety from donation through transfusion. The Hospital Division provides intravenous (IV) therapies, clinical nutrition products and hospital pharmacy systems, including systems that automate drug compounding and control drug inventory.
Grifols is headquartered in Barcelona, Spain and has 18,300 employees in 30 countries.
In 2017, sales exceeded 4,300 million euros. Grifols demonstrates its strong commitment to advancing healthcare by allocating a significant portion of its annual income to research, development and innovation.
The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex- 35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the US NASDAQ via ADRs (NASDAQ:GRFS).
Product registration and availability vary by country.
Procleix is a registered trademark of Grifols Worldwide Operations Limited.
Panther is a registered trademark of Hologic, Inc.
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