Hologic SARS-CoV-2 assay receives amended EUA

Oct. 9, 2020

Hologic announced that the U.S. Food and Drug Administration (FDA) amended a previously issued emergency use authorization (EUA) to allow the company’s Aptima SARS-CoV-2 assay to be used for testing people without symptoms, as well as for the use of a pooled sampling protocol for symptomatic patients, according to a press release.

The authorization follows a recent announcement of similar expanded uses for Hologic’s Panther Fusion SARS-CoV-2 assay.

To date, Hologic has produced tens of millions of SARS-CoV-2 assays, thereby making a significant contribution to the global testing supply. The Aptima and Panther Fusion SARS-CoV-2 tests run on Hologic’s fully automated Panther and Panther Fusion systems, respectively, each of which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.

More than 2,000 Panther and Panther Fusion systems have been installed in clinical diagnostic laboratories around the world.

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