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

By LabMedica International staff writers
Posted on 29 Sep 2020
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Image: Panther Fusion SARS-CoV-2 assay (Photo courtesy of Hologic, Inc.)
Image: Panther Fusion SARS-CoV-2 assay (Photo courtesy of Hologic, Inc.)
Hologic, Inc.’s (Marlborough, MA, USA) Panther Fusion SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

The Panther Fusion SARS-CoV-2 test runs on Hologic’s fully automated Panther Fusion system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Hologic’s assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people. A recent report published by the FDA compared more than 50 COVID-19 tests and demonstrated that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market. High analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.

The US Centers for Disease Control and Prevention (CDC) had 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. The Panther Fusion SARS-CoV-2 test 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.

“Accurately identifying individuals early in the course of infection - so they can quarantine before passing on the virus - is critical to stemming the spread of this pandemic,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available.”

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