Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay

Testing of Pooled Samples Also Authorized; New Claims Expected to Help Limit Spread of COVID-19, Open Economy and Schools –

Hologic, Inc. (Nasdaq: HOLX) announced today that its Panther Fusion® SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (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.1

“Accurately identifying individuals early in the course of infection –

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