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Hologic granted FDA emergency authorization for its COVID-19 test

Hologic granted FDA emergency authorization for its COVID-19 test

STL NEWS – Hologic announced today that it has received Emergency Use Authorization (EUA) from the U.S. 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, more than 1,000 of which are already installed in clinical laboratories throughout the United States.  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.  Combining significant manufacturing capacity for the new test with the world’s largest installed base of high-throughput molecular instruments is expected to dramatically increase testing capabilities.

“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.”

Read the full article here.

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