Grifols receives FDA clearance for AlphaID™ At Home, the first free service for U.S. consumers to determine their risk for alpha-1

Barcelona, Spain, Nov. 3, 2022 – 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.