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.
“Early diagnosis of the coronavirus is critical both to managing infected patients and to mitigating the spread of the disease,” Maurice Exner, vice president of research and development and clinical affairs at Hologic, said in a press release. “The EUA for our SARS-CoV-2 assay on the Panther Fusion system allows laboratories to run many more tests per day than they can on manual systems, enhancing the public health fight.”
Hologic expects to provide its laboratory customers with tens of thousands of SARS-CoV-2 tests this month and expects to produce nearly 600,000 SARS-CoV-2 tests a month starting in April.