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FDA Clears Grifols AAT Deficiency Test, OraSure Saliva Collection Device for Over-the-Counter Use

NEW YORK — Grifols said on Thursday that it has received US Food and Drug Administration clearance for direct-to-consumer use of AlphaID, its cheek swab-based test for alpha1-antitrypsin (AAT) deficiency.

Separately, OraSure Technologies said that its ORAcollect Dx collection device was cleared by the agency for over-the-counter use. The device can be used to support screening using Grifols' AlphaID test.

ATT deficiency is an inherited disorder that can lead to lung and liver damage and is a common risk factor for chronic obstructive pulmonary disease (COPD). In late 2019, the FDA cleared AlphaID, which screens for genetic mutations commonly associated with the condition, for use by doctors to screen COPD patients.

Barcelona, Spain-based Grifols said that the FDA has now cleared the test for use with saliva samples collected at home using OraSure's ORAcollect Dx collection device. ORAcollect Dx had previously been available by prescription only.