Grifols announced that its AlphaID(TM) At Home Genetic Health Risk Service, the first-ever free direct-to-consumer program in the U.S. to screen for genetic risk of alpha(1) - antitrypsin deficiency (alpha-1), has been cleared by the U.S. Food and Drug Administration (FDA). The service, also known as AlphaID(TM) At Home, is the company's first FDA clearance for direct-to-consumer use. It will be available beginning in Second Quarter 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. 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 alpha(1) -antitrypsin (AAT). They are encouraged to share the results with their doctor and discuss potential treatment options. A user comprehension study for AlphaID(TM) 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(TM) 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.