FDA clears at-home screening tool to assess risk for lung, liver disease linked to alpha-1

Grifols announced that its at-home service to test for genetic risk related to alpha₁-antitrypsin deficiency has received clearance from the FDA.

Through a saliva sample, the program (AlphaID At Home) will let individuals know if they are at risk for developing specific lung and/or liver diseases by screening for 14 commonly reported genetic mutations related to alpha₁-antitrypsin deficiency (alpha-1), according to a press release from the company. Alpha-1 is the most common risk factor for COPD, according to the release, although it is estimated that 90% of individuals with alpha-1 are undiagnosed.

Individuals will be able to access the test without a prescription from their health care provider, and will send their sample to a lab, with results available in a few weeks on an online portal, according to the release.

“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,” Antonio Martínez, president of Grifols Diagnostic, said in the release. “As leaders in alpha-1 testing and treatment, Grifols is redoubling its commitment to the alpha-1 community.”

AlphaID At Home will be available in the second quarter of 2023.