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Hologic Granted FDA Emergency Use Authorization for Its Second Molecular Test for COVID-19

May 15, 2020

Via: BioSpace

Hologic, Inc. (Nasdaq: HOLX) announced today that it has 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 already installed in clinical laboratories throughout the United States. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Hologic has begun distributing its new coronavirus test, and expects to produce an average of one million tests per week.

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