Hologic granted FDA EUA for asymptomatic testing, pooling protocols

Sept. 29, 2020

Hologic announced 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 people without symptoms of a COVID-19 infection, according to a press release.

The FDA EUA also authorizes Hologic’s sample pooling protocol for testing symptomatic people with the Panther Fusion SARS-CoV-2 assay. Hologic’s pooling protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. In cases of a positive result, all five samples are retested individually to determine which patient or patients are infected.

The asymptomatic screening authorization was based on available analytical data as well as Hologic’s commitment to submit results from an ongoing clinical evaluation that is underway with several laboratory partners, according to Hologic.

“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.

Hologic is also pursuing an EUA for asymptomatic testing for its Aptima SARS-CoV-2 assay, another molecular diagnostic test for COVID-19.

The Panther Fusion SARS-CoV-2 test runs on Hologic’s Panther Fusion system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.

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