Grifols, a diagnostic company based in Barcelona, Spain, has received Food and Drug Administration approval for a new genetic test to diagnose alpha-1 antitrypsin deficiency. This marks the first time the agency has approved a molecular assay for this condition. Known as the A1AT Genotyping test, it analyzes in a single reaction 14 mutations in the SERPINA1 gene that comprise the majority of the most prevalent known genetic alterations that cause alpha-1 antitrypsin deficiency. The test can be performed on 192 samples simultaneously per kit and is designed for use with DNA extracted from venous blood samples as well as from dried blood spots. Developed by Progenika Biopharma, a Grifols subsidiary, the A1AT Genotyping test previously received CE marking in December 2016.