Grifols launches AlphaID™ At Home, enabling U.S. consumers to self-screen for genetic COPD

Barcelona, Spain, May 11, 2023 – 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.