May 7, 2020

Grifols Procleix Panther System with Automation Ready Technology (ART) receives FDA Approval

  • ART enables greater workflow efficiency and lean sample management, supporting laboratories’ path towards total automation
  • The Procleix Panther System featuring ART improves system usability, increases operator walk-away time, and allows laboratories to select efficient configurations for current or future blood donor screening automation needs
  • The Grifols ART program is a cross-platform, long-term research and development initiative to enable ongoing advancements in laboratory workflow optimization

Barcelona, May 7, 2020 - 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, today announced that it has received  FDA approval for the Procleix Panther System featuring ART for use with the following U.S. licensed products: Procleix Ultrio Elite Assay, Procleix WNV Assay, Procleix Zika Virus Assay and the Procleix Babesia Assay.

Built on the success of the Procleix Panther System, ART technology features significant hardware and software improvements that support blood-banking operations of all sizes, such as instrument networkability and information sharing.

ART supports laboratory efforts to reach complete sample automation. It offers increased control over workflow and personnel utilization, from standard processes to the more complex. It also enables simplified user management through the connection of multiple instruments to a track system for automated sample handling.

The Procleix Panther System featuring ART is expected to reinforce the company’s leadership in this market segment. It has been available since October 2019 in all markets accepting the CE-mark.

“The FDA approval provides another important recognition for Grifols and its commitment to offer innovative solutions to our U.S. customers, especially during these trying times where increased automation may allow key laboratory personnel to be allocated to other priority tasks,” said Carsten Schroeder, President and CEO, Grifols Diagnostic Solutions Inc. “As market leaders in the donor screening segment, Grifols will continue to partner with blood banks worldwide as part of our mission to improve patient well-being and blood safety.”

About the Procleix Panther System

The Procleix Panther System automates all aspects of NAT (Nucleic Acid Technology)-based blood screening on a single, integrated platform, and is capable of delivering the highest result throughput per square meter. It eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use.

ART technology enhancements further increase the system’s versatility, offering customizable options and more on-demand features to fit the evolving needs and budgets of blood banks worldwide.

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 viruses (A, B, C and E), West Nile virus, SARS-CoV-2*, Zika virus, Dengue virus, Babesia, and more. 

Product registration and availability vary by country.
Procleix is a registered trademark of Grifols Worldwide Operations Limited.
Panther is a registered trademark of Hologic, Inc.
*in development. Performance characteristics have not been established