Grifols has introduced its direct-to-consumer programme, AlphaID At Home Genetic Health Risk Service (AlphaID At Home), in the US.
The new programme will help screen for the genetic risk of alpha1-antitrypsin deficiency (alpha-1), which is also called genetic chronic obstructive pulmonary disease.
In November 2022, the US Food and Drug Administration (FDA) approved AlphaID At Home for direct-to-consumer use.
The test can screen for the most prevalently reported genetic mutations linked to alpha-1, including the S, Z, F and I alleles, as well as rare and null alleles.
It utilises the same precise genotyping test manufactured by the company and provided to physicians worldwide since 2018 for alpha-1 screening.
Grifols Diagnostic president Antonio Martínez said: “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.”
AlphaID At Home is now accessible for ordering in the US at no cost via a secure online portal that complies with HIPAA standards.
After receiving the at-home screening kit, individuals can easily collect their saliva sample and send it to a laboratory adhering to the Clinical Laboratory Improvement Amendments standards for further processing.
Individuals can access their genetic results through a secure online portal after a few weeks.
Alpha-1 Foundation president and CEO Scott Santarella said: “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.”