Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays

- Grifols Procleix Ultrio Elite assay screens for HIV-1, HCV, and HBV and detects HIV-2; the Procleix WNV assay screens for West Nile virus

- Both assays are approved to run on the fully automated NAT blood screening platform Procleix Panther system

- These FDA approvals demonstrate Grifols ongoing commitment to Research, Development and Innovation with focus on improving blood safety

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Grifols

Jun 19, 2018, 08:25 ET

BARCELONA, Spain, June 19, 2018 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P andNASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that it has received approval from the U.S. Food & Drug Administration (FDA) for two blood screening assays: Procleix Ultrio Elite and Procleix WNV. Procleix Ultrio Elite is an assay that allows for increased blood safety by screening and delivering simultaneous results for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), and hepatitis B virus (HBV) as well as detecting HIV type 2 (HIV-2). The Procleix Ultrio Elite assay can be used to test pools of plasma composed of up to 96 individual donations from donors of source plasma. Procleix WNV assay is a highly sensitive, qualitative in vitro nucleic acid assay for the detection of West Nile virus RNA in plasma and serum of human blood donors.

"These FDA approvals demonstrate our ongoing commitment to expand Grifols comprehensive Nucleic Acid Testing (NAT) solutions portfolio to help labs administer NAT," said Carsten Schroeder, President, Grifols Diagnostic Division. "The addition of the Procleix Panther system with these assays will allow blood centers to efficiently screen for infectious diseases on one simple, automated platform while adapting to changes in donation volume and regulatory requirements."

Both assays will run on the fully automated NAT blood screening platform Procleix Panther system. The device is an integrated nucleic acid testing system that fully automates all necessary steps to perform Procleix assays, from sample processing through amplification, detection, and data reduction. The Procleix Panther system was created to be a fully automated sample-to-result instrument that eliminates the need for batch processing.

Grifols will begin commercializing the Procleix Ultrio Elite and Procleix WNV assays in the U.S. later this year.

The Procleix Panther system received CE Mark and launched in Europe in 2012. In June 2016, the FDA allowed blood centers the use of Grifols Procleix Zika virus assay with the Procleix Panther system, under an Investigational New Drug study protocol, to screen donated blood nationwide.

About Grifols
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 190 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). For more information, visit www.grifols.com.

SOURCE Grifols