- AlphaID™ At Home, the company's first FDA clearance for
direct-to-consumer use, enables U.S. adults to screen for their
genetic risk of alpha1-antitrypsin deficiency (alpha-1)
without prescription from a healthcare professional
- A simple saliva sample collected at home will detect the
chances of developing lung and/or liver disease linked to alpha-1,
including chronic obstructive pulmonary disease (COPD), a group of
respiratory illnesses
- During November, awareness month for both alpha-1 and COPD,
Grifols underscores its longtime commitment to the alpha-1
community and identifying more COPD patients with alpha-1
BARCELONA, Spain, Nov. 3, 2022
/PRNewswire/ -- Grifols (MCE: GRF) (MCE:GRF.P) (NASDAQ:GRFS), a
global leader in plasma-derived medicines and innovative diagnostic
solutions, today announced that its AlphaID™ At Home Genetic Health
Risk Service, the first-ever free direct-to-consumer program in the
U.S. to screen for genetic risk of alpha1-antitrypsin
deficiency (alpha-1), has been cleared by the U.S. Food and Drug
Administration (FDA).
The service, also known as AlphaID™ At Home, is the company's
first FDA clearance for direct-to-consumer use. It will be
available beginning in Q2 2023 for U.S. adults to screen for their
genetic risk level of developing lung and/or liver disease related
to alpha-1 without a medical prescription.
Alpha-1 is the most common risk factor for chronic obstructive
pulmonary disease (COPD), a group of respiratory diseases that
includes emphysema and chronic bronchitis. It's estimated that
around 16 million Americans have COPD, with millions more yet to be
diagnosed.[1] More than 90% of people with alpha-1 are believed to
be undiagnosed.[2]
"Many COPD patients don't know their condition could be caused
by alpha-1 because its symptoms are similar to those of COPD or
asthma," said Scott Santarella,
President & CEO of the Alpha-1 Foundation, pointing out that
November is awareness month for both alpha-1 and COPD. "We
wholeheartedly support initiatives and innovations that contribute
to the diagnosis of alpha-1."
To use the safe saliva collection kit, individuals simply
collect their sample and send it to a certified lab for processing.
Within a few weeks and through a secure online portal, they will
know if they are at risk of developing alpha-1, a condition due to
a lack of alpha1-antitrypsin (AAT). They are encouraged
to share the results with their doctor and discuss potential
treatment options.
A user comprehension study for AlphaID™ At Home showed that a
demographically diverse U.S. population of users (525 participants)
could easily comprehend the service reports, with a 90% or greater
rate of understanding.
AlphaID™ At Home uses the same accurate test Grifols has 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 technology over the last 20 years.
The test can screen 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.
"Grifols is very pleased that the FDA cleared the AlphaID™ At
Home service, reflecting the robustness and accuracy of the testing
platform as well as the value it will provide in helping people
detect if they are at risk for alpha-1," said Antonio Martínez,
President of Grifols Diagnostic. "As leaders in alpha-1 testing and
treatment, Grifols is redoubling its commitment to the alpha-1
community."
Only a physician or healthcare provider can make a diagnosis of
alpha-1. To learn more about alpha-1, please visit the Alpha-1
Foundation at www.alpha1.org.
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 our ever-growing knowledge of many chronic,
rare and prevalent conditions, at times life-threatening, drive our
innovation in plasma-based therapies 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 400
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. We provide high-quality biological supplies for
life-science research, clinical trials, and for manufacturing
pharmaceutical and diagnostic products. 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 27,000 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 2021, Grifols' economic impact in its core countries of
operation was EUR 7.7 billion. The
company also generated 141,500 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 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.
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[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.
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SOURCE Grifols