* Grifols' in vitro nucleic acid test detects four types of arboviruses,

    helping mitigate the risk of transfusion-transmitted infections
  * Arboviruses are a growing emerging threat, with changes in climate and
    increasing global connectivity making the geographic spread more prevalent
  * CE mark for Grifols' Procleix ArboPlex Assay reinforces the company's
    leadership in transfusion medicine and commitment to ensuring the safety of
    the world's blood supply

BARCELONA, Spain, April 04, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE:
GRF.P NASDAQ: GRFS), one of the world's leading producers of plasma-derived
medicines and innovative diagnostic solutions, today announced that its new
Procleix ArboPlex Assay has obtained the CE mark under the In Vitro Diagnostic
Regulation (IVDR), the first for an automated nucleic acid test (NAT)
specifically validated for screening blood donors to detect four major
arboviruses: chikungunya, dengue, West Nile and Zika viruses.
These are the four most significant arboviruses of concern, all spread through
mosquito vectors. Changes in climate and increasing global connectivity have
made the geographic spread of - and growing exposure to - arboviruses a major
public health concern. With the dengue virus alone, there were more than 5
million cases and 5,000 deaths reported globally in 2023.(1)
Further strengthening the Grifols Procleix portfolio for blood donor screening,
the Procleix ArboPlex Assay uses plasma or serum samples to detect arboviral
RNA. Currently, risk for arboviruses in blood donors is evaluated either with a
monoplex test, duplex test or through a questionnaire in which donors who
declare having traveled to or prior residence in arbovirus-endemic areas are
temporarily deferred. Blood banks and collection centers could decide that
deferrals are unnecessary if donors were tested and found negative using the
Procleix ArboPlex Assay.
"With its 4-in-1 arbovirus test feature, the Grifols Procleix ArboPlex Assay has
the ability to speed up and overall improve donor screening laboratory
efficiency," said Antonio Martínez, president of Grifols Diagnostic Business
Unit. "Certification of this new assay provides a reliable and efficient
solution to ensure accurate and consistent results, demonstrating Grifols'
continued commitment to innovating blood screening safety."
The Procleix ArboPlex Assay will be available in all markets accepting the CE
mark certification after completion of any additional registration and
notification requirements.
About Procleix ArboPlex Assay(®
)The Procleix ArboPlex Assay is a nucleic acid test (NAT) that uses magnetic-
based target capture, Transcription-Mediated Amplification (TMA) and
chemiluminescence to detect the presence of RNA sequences of four arboviruses
(chikungunya virus, dengue virus RNA, West Nile virus RNA, and Zika virus) in
plasma and serum from human donors. The high sensitivity and specificity of the
Procleix technology enables pathogen detection to reduce the risk of transfusing
infected blood or blood components, even when the donor does not exhibit
symptoms. The assay runs on the widely adopted Procleix Panther System, an
automated NAT instrument from Grifols.
About Procleix Panther System
The Procleix Panther System automates all aspects of NAT-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. For more
information, please visit www.diagnostic.grifols.com
(http://www.diagnostic.grifols.com).
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. A leader in
essential plasma-derived medicines and transfusion medicine, the company
develops, produces and provides innovative healthcare services and solutions in
more than 110 countries.
Patient needs and Grifols' ever-growing knowledge of many chronic, rare and
prevalent conditions, at times life-threatening, drive the company's innovation
in both plasma and other biopharmaceuticals to enhance quality of life. Grifols
is focused on treating conditions across a broad range of therapeutic areas:
immunology, hepatology and intensive care, pulmonology, hematology, neurology
and infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its network of
donation centers, the world's largest with over 390 across North America,
Europe, Africa and the Middle East and China.
As a recognized leader in transfusion medicine, Grifols offers a comprehensive
portfolio of solutions designed to enhance safety from donation to transfusion,
in addition to clinical diagnostic technologies. It provides high-quality
biological supplies for life-science research, clinical trials, and for
manufacturing pharmaceutical and diagnostic products. The company also supplies
tools, information and services that enable hospitals, pharmacies and healthcare
professionals to efficiently deliver expert medical care.
Grifols, with more than 23,000 employees in more than 30 countries and regions,
is committed to a sustainable business model that sets the standard for
continuous innovation, quality, safety and ethical leadership.
In 2023, Grifols' economic impact in its core countries of operation was EUR
9.6 billion. The company also generated 193,000 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).
For more information, please visit: www.grifols.com (http://www.grifols.com)
MEDIA CONTACT:
Media Press Office
media@grifols.com (mailto:media@grifols.com)
Tel. +34 93 571 00 02
INVESTORS:
Investors Relations Department & Sustainability
inversores@grifols.com (mailto:inversores@grifols.com) - investors@grifols.com
(mailto:investors@grifols.com)
Tel. +34 93 571 02 21
LEGAL DISCLAIMER
The facts and figures contained in this report that do not refer to historical data are "future projections and assumptions". Words and expressions such as "believe", "hope", "anticipate", "predict", "expect", "intend", "should", "will seek to achieve", "it is estimated", "future" and similar expressions, insofar as they relate to the Grifols group, are used to identify future projections and
assumptions. These expressions reflect the assumptions, hypotheses, expectations
and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of
competitor products on the market, or changes to the regulatory framework of the
markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005,
of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the
Grifols group.
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¹ https://www.who.int/emergencies/disease-outbreak-news/item/2023- DON498 accessed March 2024
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