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Grifols Wins FDA Approval for AAT Deficiency Test

NEW YORK (GenomeWeb) – Spanish healthcare products firm Grifols announced today that it has received US Food and Drug Administration approval for its blood-based alpha-1 antitrypsin (AAT) deficiency test.

AAT deficiency is caused by mutations in the SERPINA1 gene and leads to decreased activity of the protease inhibitor alpha-1 antitrypsin in the blood and lungs, resulting in lung dysfunction. It can also include the accumulation of a mutant AAT protein in liver tissue, leading to liver injury, fibrosis, cirrhosis, and potentially liver cancer.

Developed by Grifols subsidiary Progenika Biopharma, the test is designed to detect 14 of the most prevalent known SERPINA1 mutations and is capable of simultaneously analyzing 192 samples per kit. It is now approved in the US for use with DNA extracted from either a blood sample or a dry blood spot.

Grifols said that the test, which was CE marked about a year ago, represents part of its growth strategy for its Prolastin-C line of AAT augmentation and maintenance therapy products.

Grifols' emphasis on the diagnostics space began in earnest about three years ago, and was recently given a boost by its $1.85 billion cash purchase earlier this year of Hologic's share in an existing joint-business for NAT-based blood screening. In July, the company reported revenues in its diagnostics division rose by 11 percent during the first half of 2017 to €351.1 million ($410.8 million), compared to €316.8 in the first half of 2016.