Select American Red Cross Blood Donations Screened for Babesia Parasite Using Grifols' Procleix Babesia Assay Under an Investigational New Drug Protocol


01.08.2017

  • American Red Cross is testing selected donations collected in areas of the U.S. that are endemic for the tick known to carry the Babesia parasite
  • The data collected will be used in the submission process to seek FDA  approval for Grifols Procleix Babesia assay, which is designed to be used for routine screening by U.S. blood banks on the Procleix® Panther® system
  • Procleix® Panther® system is designed as a fully automated platform utilizing Nucleic Acid Technology (NAT) for blood screening


Barcelona, August 1, 2017 - 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, announced today that the American Red Cross laboratory in Charlotte, North Carolina now screens blood samples collected in the states of New Jersey, Pennsylvania, Maryland, Maine, Vermont, and New Hampshire with the Procleix Babesia assay under an Investigational New Drug (IND) study.

The Procleix Babesia assay is designed to be a qualitative in vitro nucleic acid screening test for the direct detection of the Babesia parasite in whole blood specimens from human blood donors on the fully automated Procleix Panther system platform. The parasite is transmitted to humans primarily through tick bites but can be transmitted through blood, which underscores the importance of this screening. The data collected will be used in the submission process to seek FDA approval for the Procleix Babesia assay, which is designed to be used for routine screening by U.S. blood banks on the Procleix® Panther® system.

"The Red Cross is excited to participate in this timely critical trial. The availability of a sensitive and specific nucleic acid test to decrease the incidence of transfusion-transmitted Babesia throughout the endemic areas of the U.S. will be an important accomplishment," said Dr. Susan Stramer, Ph.D., Vice President, Scientific Affairs at the Red Cross.

"We are very pleased that the Red Cross joins Grifols' efforts and strong commitment to blood safety. This collection of clinical data will be used to register the assay for use in the U.S. market," said Grifols Diagnostic Commercial Operations President, Carsten Schroeder. "As the worldwide market leader of NAT blood donor screening, we consider it our duty to work with the appropriate institutional and scientific stakeholders worldwide to address any threat to the blood supply."

About Babesia

Babesia is caused by microscopic parasites and is transmitted primarily through tick bites. However, as the disease is spread during the nymph stage, many patients are unaware of a tick encounter. There may be no symptoms, or those affected may experience flu-like symptoms. The disease destroys red blood cells and can lead to hemolytic anemia (jaundice and hemoglobinuria). Individuals with compromised immune systems may experience more severe complications. Although widespread, the main concentrations of the disease are found in the Northeastern and Midwestern portions of the U.S., according to the Centers for Disease Control and Prevention (CDC). The latest data from the CDC show more than 1,700 people were affected by Babesia in 2014 with highest concentrations in Massachusetts, New York, Connecticut, Rhode Island, New Jersey, Maine, New Hampshire, Wisconsin, and Minnesota.

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 (A, B, C and E) viruses, 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 the American Red Cross

The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies about 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. For more information, please visit redcross.org or cruzrojaamericana.org; or visit us on Twitter @RedCross.

 

Product registration and availability vary by country.
The Procleix Babesia Assay is under development and not yet available for sale.
Procleix is a registered trademark of Grifols Worldwide Operations Limited.
Panther is a registered trademark of Hologic, Inc.