Investigational New Drug Application is Now Effective for Babesia Screening in Blood Donations Using Grifols Procleix Panther System in the US


10.05.2017

  • Test is designed to detect the presence in whole blood, of the four clinically relevant species of Babesia (B. microti, B. duncani, B. divergens, and B. venatorum), a parasite that can be transmitted to humans by tick bite or through blood donations from Babesia-infected donors
  • FDA has allowed the use of the test under an Investigational New Drug (IND) study for selected blood banks in the U.S.
  • Procleix® Panther® system is a fully automated platform utilizing Nucleic Acid Technology (NAT) for blood screening

Barcelona, May 9, 2017 - Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS) announces that the U.S. Food and Drug Administration (FDA) has allowed collection and testing of blood samples for screening with Procleix Babesia assay under an Investigational New Drug (IND) study.

Babesia is caused by microscopic parasites and is transmitted primarily through tick bites. However, as the disease is spread during ticks' young 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 Center for Disease Control (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.

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 specimens from human blood donors on the fully automated Procleix Panther system platform. This test, developed by Grifols Diagnostic Solutions, Inc., is designed to enable participating blood banks and donor centers in the U.S. to test donations to further safety of their blood supplies.

"The availability of the assay under the IND protocol and in collaboration with the FDA marks another important milestone for Grifols," said Grifols Diagnostic Division President, Carsten Schroeder. "As leaders in the NAT blood screening market, we remain committed to preserve the safety of blood donations from the presence of unwanted pathogens. The Procleix Babesia assay will add to our growing portfolio and has been expressly designed to address the needs of the blood banking community."

Currently, the majority of blood donations in the U.S. are being tested with the Procleix Zika virus assay (on the Procleix Panther system), released in June 2016 under an IND study.

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.