Hologic’s molecular test for the novel Coronavirus, SARS-CoV-2, receives FDA Emergency Use Authorization
On Mar. 16, 2020, Hologic announced the U.S. Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA) for the Company;s new Panther Fusion SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease.
Hospital, public health and reference laboratories can perform the test on Hologic’s Panther Fusion system, a fully automated, high-throughput molecular diagnostic platform that is widely used across the United States. Each Panther Fusion system can provide results in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period.
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Source: Hologic, Inc.
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