Grifols Launches AlphaID™ At Home, Enabling U.S. Consumers to Self-Screen for Genetic COPD

• Now available in the U.S., this free, innovative genetic health risk service lets consumers screen for their risk of alpha₁-antitrypsin deficiency (alpha-1) through a small saliva sample they can collect right at home without needing to visit a healthcare professional
  
• Alpha-1 is the most common genetic risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases affecting around 16 million Americans and the fourth-leading cause of death in the U.S.¹
• As the leader in alpha-1 screening, Grifols wants to reach the more than 90% of people with alpha-1 believed to be undiagnosed²

BARCELONA, Spain, May 11, 2023 (GLOBE NEWSWIRE) — Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global leader in plasma-derived medicines and innovative diagnostic solutions, today announced it has launched its AlphaID™ At Home Genetic Health Risk Service (AlphaID™ At Home), the first-ever free direct-to-consumer program in the U.S., to screen for the genetic risk of alpha₁-antitrypsin deficiency (alpha-1).

Alpha-1, also known as genetic COPD (chronic obstructive pulmonary disease), is estimated to impact 1 in every 2,500 Americans.³ With AlphaID™ At Home people can collect a small saliva sample without needing to visit a healthcare professional to learn their risk of developing lung and/or liver disease linked to alpha-1.

Genetic COPD develops due to a genetic deficiency of alpha₁ antitrypsin, a protective plasma protein that safeguards the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. Many COPD patients don’t realize their condition could have a genetic component, even though medical guidelines and the COPD Foundation suggest they get screened to learn their genetic risk for alpha-1.

“Given the fact that it can take several years until a patient with alpha-1 is properly diagnosed, AlphaID™ At Home can indicate someone’s risk for alpha-1 in a matter of weeks,” said Antonio Martínez, President of Grifols Diagnostic. “It’s a patient-friendly way to make a sophisticated genetic test simple and understandable.”

Pia D’Urbano, President of Grifols Biopharma, added: “Our hope is that through AlphaID™ At Home we can increase awareness about alpha-1 and accelerate diagnosis through the ease of at-home testing. This important screening service further strengthens Grifols’ firm commitment to the alpha-1 community.”

“We wholeheartedly support initiatives and innovations that contribute to the diagnosis of alpha-1. As leaders in alpha-1 testing, Grifols is doubling down on its commitment to the alpha-1 community by making it easier and more efficient to get diagnosed,” said Scott Santarella, President & CEO of the Alpha-1 Foundation. “This is incredible news for our community and will help patients go on to lead healthier lives.”

AlphaID™ At Home is now available to order in the U.S. without cost through a secure HIPAA-compliant online portal. Once the at-home screening kit arrives, individuals simply collect their saliva sample and send it to a CLIA-certified lab for processing. After a few weeks, they can access their genetic results on the secure online portal. Individuals are encouraged to share the results with their doctor, as only a healthcare provider can make a diagnosis of alpha-1.

Cleared by the U.S. Food and Drug Administration (FDA) in November 2022 for direct-to-consumer use*, AlphaID™ At Home screens for the 14 most prevalently reported genetic mutations associated with alpha-1 – the most of any test of its kind – including the S, Z, F, I alleles, as well as rare and null alleles.

AlphaID™ At Home uses the same accurate genotyping test Grifols has manufactured and made available to physicians globally since 2018 to screen for alpha-1, a focus on diagnosis that has led to more than 1 million patients being screened with Grifols solutions over the last 20 years.

To order a free AlphaID™ At Home kit, please visit www.alphaidathome.com.

To learn more about genetic COPD, please visit www.geneticCOPDtest.com.

To learn more about alpha-1, please visit the Alpha-1 Foundation at www.alpha1.org.

*AlphaID™ At Home is cleared for U.S. residents 18 years or older. The receipt of this free testing service does not create any expectation or obligation to purchase or use any product or service offered by any manufacturer.

For media inquiries:

Caleb Fernandez-Schendt
caleb.fernandezschendt@grifols.com
(919) 316-2128

Grifols Press Office
media@grifols.com        
Tel. +34 93 571 00 02

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 more than 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 24,000 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 2022, 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  

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, in so far 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 Chronic Obstructive Pulmonary Disease. Centers for Disease Control and Prevention. Accessed October 31, 2022. Chronic Obstructive Pulmonary Disease (COPD) | CDC
² Campos MA, Wanner A, Zhang G, Sandhaus RA. Trends in the diagnosis of symptomatic patients with α1-antitrypsin deficiency between 1968 and 2003. Chest. 2005;128(3):1179-1186.
³ Alpha-1 Foundation, Alpha-1 Fast Facts