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FDA Revises Hologic Emergency Use Authorization to Include Asymptomatic Testing of SARS-CoV-2

NEW YORK ─ The US Food and Drug Administration has amended an Emergency Use Authorization for Hologic's Aptima SARS-CoV-2 assay to include testing of people without symptoms or other reasons to suspect COVID-19 infection, the company said on Tuesday.

The FDA had granted EUA for the Aptima SARS-CoV-2 molecular assay in May for symptomatic testing.

Marlborough, Massachusetts-based Hologic said that the FDA further amended that initial EUA to include the firm's pooling protocol for symptomatic testing.

The FDA amendment follows an announcement last week of similar claims for Hologic's Panther Fusion SARS-CoV-2 assay.

Molecular tests remain the most sensitive and accurate of the available options for infectious disease diagnostic testing, "which is particularly important when screening individuals with no symptoms or known contact with infected people, and therefore no clues about their infectious state," Kevin Thornal, president of Hologic's diagnostic solutions division, said in a statement.

The Aptima and Panther Fusion SARS-CoV-2 tests run on Hologic's fully automated Panther and Panther Fusion systems, respectively.

Each system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours, Hologic said. More than 2,000 Panther and Panther Fusion systems have been installed in clinical diagnostic laboratories around the world, the firm added.