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May 8, 2020

Grifols secures FDA approval for Procelix Panther System

Grifols has secured approval from the US Food and Drug Administration (FDA) for its Procelix Panther System featuring Automation Ready Technology (ART).

Grifols has secured approval from the US Food and Drug Administration (FDA) for its Procelix Panther System featuring Automation Ready Technology (ART).

This system automates all aspects of Nucleic Acid Technology (NAT)-based blood screening on a single, integrated platform. It is claimed to deliver the highest result throughput per square metre.

ART technology enhancements provide the system with customisable options and more on-demand features and support laboratory efforts to reach complete sample automation.

The technology is claimed to support blood-banking operations of all sizes including instrument networkability and information sharing.

Furthermore, it provides better control over workflow and personnel utilisation, from standard processes to the more complex ones. It also allows simplified user management through the connection of multiple instruments to a track system for automated sample handling.

Grifols Diagnostic Solutions president and CEO Carsten Schroeder said: “The FDA approval provides another important recognition for Grifols and its commitment to offer innovative solutions to our US customers, especially during these trying times where increased automation may allow key laboratory personnel to be allocated to other priority tasks.

“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.”

The FDA clearance allows the system for use with Procleix Ultrio Elite Assay, Procleix WNV Assay, Procleix Zika Virus Assay and the Procleix Babesia Assay.

Grifols launched the Procleix Panther System last October in countries accepting the CE mark.

Procleix systems are used to screen blood donations around the world including tests for HIV, hepatitis A, B, C and E, West Nile virus, and Zika virus among others.

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