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 SystemThe
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.
About GrifolsGrifols 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
MEDIA CONTACT:
Media Press
Officemedia@grifols.comTel. +34 93 571 00 02
INVESTORS: Investors
Relations Department &
Sustainabilityinversores@grifols.com – investors@grifols.com
Tel. +34 93 571 02 21
LEGAL DISCLAIMERThe 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.
________________________¹
https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON498 accessed
March 2024
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