GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach® Anti-SARS-CoV-2 Total Test.
The authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour – and will eventually also run the antigen test.