Grifols receives FDA clearance for AlphaID At Home

Nov. 7, 2022
The free service for U.S. consumers to determine their risk for alpha-1.

Grifols announced that its AlphaID At Home Genetic Health Risk Service, the 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.

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.

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 release