Hologic’s test for SARS-CoV-2 receives EUA

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March 17, 2020—Hologic announced on March 16 that the FDA granted emergency use authorization for its Panther Fusion SARS-CoV-2 assay. The real-time RT-PCR in vitro diagnostic test is intended for the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal and oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.

The test is for use on Hologic’s Panther Fusion system, a fully automated, high-throughput molecular diagnostic platform that provides results in less than three hours and processes up to 1,150 coronavirus tests in a 24-hour period.