People in the United States will now be able to self-screen for the genetic risk of alpha-1 antitrypsin deficiency (AATD) using the AlphaID™ At Home Genetic Health Risk Service (AlphaID™ At Home), Grifols announced.
“Given the fact that it can take several years until a patient with alpha-1 [AATD] is properly diagnosed, AlphaID™ At Home can indicate someone’s risk for alpha-1 [AATD] 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.”
AlphaID At Home is a self-screening kit that people can use to collect a saliva sample and send it to a Clinical Laboratory Improvement Amendments (CLIA)-certified lab for processing. The genetic testing results will be available online through a secure online portal after a few weeks.
Further, patients are encouraged to share the test results with their doctor, as only a healthcare provider can establish a diagnosis of AATD.
Read more about AATD testing
The AlphaID At Home testing kit screens for the 14 most common AATD-associated genetic mutations, including the S, Z, F, and I alleles, as well as rare and null alleles. It uses the exact AATD genotyping test Grifols manufactured in 2018 for physicians globally.
The at-home test was approved by the US Food and Drug Administration (FDA) in November 2022 for direct-to-consumer use and can be ordered in the US for free through a secure HIPAA-compliant online portal.
AATD, a genetic chronic obstructive pulmonary disease, is caused by the lack of alpha-1 antitrypsin and subsequent lung tissue damage. Although the condition affects approximately 1 in every 2,500 Americans, many of them do not realize their condition could have a genetic component.
Grifols launches AlphaID™ at home, enabling U.S. consumers to self-screen for genetic COPD. News release. Grifols, S.A.; May 11, 2023.