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Grifols Receives FDA Approval for Procleix Babesia Assay for Donor Screening on Procleix Panther System

07.02.2019

  • New assay enables blood banks to screen for the Babesia parasite in donated blood
  • Babesia transfusion-transmitted infections (TTIs) have been a major source of TTIs in the United States
  • Procleix Babesia assay provides U.S. blood banks the ability to screen whole blood donations for the presence of four clinically relevant species of the Babesia parasite and improve blood transfusion safety

Barcelona, Spain, February 7, 2019 – Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that the U.S. Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative assay for the detection of the ribosomal RNA from 4  Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.

The assay runs on the Procleix Panther system — a fully automated platform utilizing Nucleic Acid Testing (NAT) for blood screening. The FDA approval recognizes a successful multi-center clinical trial conducted under an Investigational New Drug (IND) study at the American Red Cross, Creative Testing Solutions, and Rhode Island Blood Center (an affiliate of the New York Blood Center, Inc.), in select areas of the U.S.

"The FDA approval of the Procleix Babesia assay is the latest significant milestone for Grifols and reinforces our strong commitment to helping health professionals decrease potential risks of infection from donated blood," said Carsten Schroeder, President of Grifols Diagnostic Commercial Division. "By monitoring new and re-emerging threats to blood supply, we continue in our mission to work with leading experts in the field and health authorities to improve patient safety by delivering innovative solutions on proven and reliable testing platforms."

Babesia is a parasite that can be transmitted to humans by tick bites or through donated blood from Babesia-infected donors. According to the Centers for Disease Control and Prevention (CDC), the highest numbers of Babesia infections occurred 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 product, and include tests for HIV, hepatitis (A, B, C and E) viruses, West Nile virus, Zika 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.