Hologic granted FDA Emergency Use Authorization for asymptomatic COVID-19 testing with Panther Fusion SARS-CoV-2 assay

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On Sept. 28, 2020, Hologic announced that its Panther Fusion SARS-CoV-2 assay had received Emergency Use Authorization (EUA) from the FDA for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

Hologic’s assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people. This availability is expected to play a key role in identifying early infection in exposed individuals, as well as reopening schools, workplaces and the economy in general.

The U.S. Centers for Disease Control and Prevention (CDC) recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus.

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Source: BusinessWire
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