FDA is still granting Emergency Use Authorization (EUA) for COVID-19 tests, even though the conversation surrounding is shifting to antibody testing.
This time Hologic has received EUA for the Aptima SARS-CoV-2 test. The Marlborough, MA-based company received authorization for a COVID-19 detection tool in March.
The Aptima SARS-CoV-2 test runs on Hologic’s Panther system. The company said each Panther system can provide initial results in about three hours and process more than 1,000 coronavirus tests in 24 hours.
The test is being distributed and Hologic said it expects to produce an average of one million tests per week.“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,” Steve MacMillan, the company’s Chairman, president and CEO, said in a release. “I’m so proud of the incredible teamwork across the company that brought this test to market so quickly.”
Hologic said it plans to register its Aptima SARS-CoV-2 assay for a CE mark later this month.