Grifols Procleix ArboPlex Assay® Receives CE Mark, the First and Only 4-in-1 NAT for Arbovirus Screening
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Insights
The CE mark approval for Grifols' Procleix ArboPlex Assay represents a significant advancement in the field of transfusion medicine. As arboviruses like chikungunya, dengue, West Nile and Zika continue to pose risks, especially in the context of global warming and increased travel, the ability to screen blood effectively is paramount. A multi-virus detection system streamlines the screening process, potentially reducing the need for donor deferral and enhancing the efficiency of blood banks. The impact on the healthcare system could be profound, as it not only safeguards the blood supply but also minimizes the economic burden of transfusion-transmitted infections.
In terms of market implications, the introduction of the Procleix ArboPlex Assay by Grifols could solidify the company's position in the diagnostic market. The demand for more sophisticated screening methods is likely to grow, influenced by the factors driving the spread of arboviruses. Grifols' innovation may lead to increased sales and market share in the diagnostic segment, potentially affecting the company's financial performance positively. However, the actual impact on the stock market will depend on how quickly and widely the new assay is adopted by blood banks and how it compares to competing products in terms of cost and reliability.
From an industry perspective, Grifols' achievement with the Procleix ArboPlex Assay could set a new standard for blood safety protocols. The ability to detect multiple arboviruses in a single test is not only a technological feat but also a strategic move that aligns with the increasing regulatory focus on blood safety. This development may spur competitors to accelerate their own research and development efforts, possibly leading to a wave of innovation in the sector. Over the long term, this could lead to improved global health outcomes and a more resilient blood supply system.
- 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.
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
MEDIA CONTACT:
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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
FAQ
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