September 30, 2020 – Hologic, Inc. (Marlborough, MA) 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 of individuals without symptoms or other reasons to suspect COVID-19 infection.
According to the company, this 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, Hologic said.
The asymptomatic screening claim was authorized 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.
Hologic is also pursuing an EUA for asymptomatic testing for its Aptima SARS-CoV-2 assay, another molecular diagnostic test for COVID-19.