Hologic’s Second Molecular Test for COVID-19 Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 16 May 2020

Hologic, Inc. (Marlborough, MA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

The newly authorized test runs on Hologic’s fully automated Panther system, a fully automated, high-throughput molecular diagnostic platform that is widely used around the world, with more than 1,800 systems installed in 60 countries and more than 1,000 systems installed in clinical laboratories across all 50 states in the US. Each Panther system can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. Hologic has begun distributing its new coronavirus test, and expects to produce an average of one million tests per week. Hologic now plans to register its Aptima SARS-CoV-2 assay for a CE Mark for diagnostic use in Europe later in May.

Image: Aptima SARS CoV-2 (Photo courtesy of Hologic, Inc.)

“Delivering test results when and where they are needed – so people can either get back to work or quarantine themselves – is key to re-opening global economies safely,” said Steve MacMillan, the company’s Chairman, President and CEO. “I’m so proud of the incredible teamwork across the company that brought this test to market so quickly.”