On May 15, 2020, Hologic announced it had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

The newly authorized test runs on Hologic’s fully automated Panther system, more than 1,000 of which are installed in clinical laboratories throughout the U.S. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.

Hologic planned to register its Aptima SARS-CoV-2 assay for a CE mark for diagnostic use in Europe later in May.