New highly sensitive test to screen donors of blood, tissues, and organs for Hepatitis E virus receives CE mark


25.07.2014

  • The test, which uses nucleic acid technology (NAT) to detect Hepatitis E virus, will run on the fully automated Procleix® Panther® system in the EU

Barcelona, July 24, 2014 Grifols (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS), one of the world's leading companies in the plasma-derived biological medicines and transfusion medicine sectors, has announced CE mark for the Procleix HEV assay. The test, developed in collaboration with Hologic, Inc. (HOLX), is the only validated NAT test designed for fully automated and highly sensitive and specific detection of Hepatitis E virus (HEV) RNA in donors of blood, blood components, tissues, and organs.

"As the leading provider of NAT solutions to support safe transfusions and efficient, high-quality testing, we are proud to have accelerated development of this test – already scheduled for use in Japan – to meet the needs of the blood community", said Carsten Schroeder, President of Grifols Diagnostic Solutions Inc.

The Procleix HEV assay is designed to detect all 4 genotypes of the hepatitis E virus. It will be sold in the EU for use on the Procleix Panther system, which offers full automation, simple operation, and a broad test menu in a small footprint. Since its launch in 2012, the Procleix Panther system has become the solution of choice for blood banks in more than 25countries, with more than 160instruments placed to date.

Procleix NAT solutions, which tests more units of donated blood worldwide than any other commercial NAT blood screening system, are developed under a long-standing partnership between Grifols and Hologic.

About the Procleix HEV Assay and the Hepatitis E Virus

The Procleix HEV assay for blood donations is a qualitative in vitro nucleic acid amplification test for the detection of Hepatitis E virus (HEV) RNA in plasma and serum specimens from human donors, tested individually or in pools. It is also intended for use in testing plasma and serum to screen organ and tissue donors, including cadaveric (non-heart-beating) donors.

The Hepatitis E virus is classified into 4 major genotypes.Genotypes 1 and 2, considered human viruses, often cause disease in the resource-limited world and are transmitted primarily through contaminated water and fecal-oral routes. Genotypes 3 and 4, commonly found in domestic and wild pigs, are found throughout the world and are the cause of human infections associated with consumption of undercooked meats and shellfish.

Clinical signs and symptoms of HEV infection include nausea/vomiting, malaise, loss of appetite, and jaundice. Infections are frequently asymptomatic, however, and the disease course is usually self-limited – with the exception of pregnant women and the immunosuppressed where fulminant hepatitis (acute liver failure) can develop.

About Grifols

Grifols is a global healthcare company with a 70-year legacy of improving people's health and well being through the development of life-saving plasma medicines, diagnostics systems, and hospital pharmacy products

The company is present in more than 100 countries worldwide and is headquartered in Barcelona, Spain. Grifols is a leader in plasma collection with a network of 150 plasma donor centers in the U.S., and a leading producer of plasma-derived biological medicines. The company also provides a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks and transfusion centers, and is a recognized leader in transfusion medicine.

In 2013, sales exceeded 2,740 million euros with a headcount of 13,200 employees. Grifols demonstrates its commitment to advancing healthcare by allocating a significant portion of its annual income to R&D.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF).  Its non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS). For more information visit www.grifols.com.