May 15, 2020—Hologic announced it has received emergency use authorization from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.
The test runs on Hologic’s fully automated Panther system, more than 1,000 of which are installed in clinical laboratories throughout the United States. The Panther system can provide initial results in about three hours and process more than 1,000 coronavirus tests in 24 hours. The company has begun distributing its new test and expects to produce an average of one million tests per week.
Hologic plans to register its Aptima SARS-CoV-2 assay for a CE mark for diagnostic use in Europe later in May.