Test Authorized for Asymptomatic COVID-19 Testing

The U.S. FDA granted Emergency Use Authorization on September 24, 2020, for Hologic’s Panther Fusion® SARS-CoV-2 test, which identifies the coronavirus causing COVID-19 by testing individuals without symptoms or other reasons to suspect COVID-19 infection. The assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people.

“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 at Hologic, in a September 28, 2020, press statement. “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.”

Hospital, public health, and reference laboratories will run Hologic’s new test on the Panther Fusion systems that are already in wide use across the USA.