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FDA Reissues Emergency Use Authorization for Hologic SARS-CoV-2 Assay for Asymptomatic Testing

NEW YORK ─ The US Food and Drug Administration has updated an Emergency Use Authorization for Hologic's Panther Fusion SARS-CoV-2 assay to enable testing people without symptoms or suspected of being infected with SARS-CoV-2 for other reasons. The FDA in March had granted EUA for the Panther Fusion SARS-CoV-2 assay to test symptomatic people.

The Marlborough, Massachusetts-based firm said on Monday that its assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people, and that its availability is expected to play a key role in identifying early infection in exposed individuals, as well as in reopening schools, workplaces, and the economy in general.

In addition, as part of the updated EUA, the FDA authorized Hologic's pooling protocol for symptomatic testing with the Panther Fusion SARS-CoV-2 assay. The protocol enables clinical laboratories to combine up to five patient samples into a single tube for processing.

A negative result means that all five people 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. A high level of analytical sensitivity is especially important when testing pooled samples, Hologic noted.

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 noted that high analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.

"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," Kevin Thornal, president of Hologic's diagnostic solutions division, said in a statement.

The FDA authorized Hologic's asymptomatic screening claim based on available analytical data as well as the company's commitment to submit results from an ongoing clinical evaluation with several laboratory partners, the firm said.

Hologic is also pursuing EUA for asymptomatic testing for its Aptima SARS-CoV-2 assay, a second molecular diagnostic test that received EUA in May for testing people with SARS-CoV-2 symptoms. 

Hologic noted that the US Centers for Disease Control and Prevention recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals.