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

BARCELONA, Spain, May 7, 2020 /PRNewswire/ -- 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.

About Grifols

Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. Its four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services that are sold in more than 100 countries.

Pioneers in the plasma industry, Grifols operates a growing network of donation centers worldwide. It transforms collected plasma into essential medicines to treat rare, chronic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. In addition, the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.

Grifols, with more than 24,000 employees in 30 countries, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.

In 2019, Grifols' economic impact in its core countries of operation was 8.5 billion euros. The company also generated 148,000 jobs, including indirect and induced.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).

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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

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SOURCE Grifols, SA