MarketWatch: Hologic Gets Emergency Use Authorization for Its COVID-19 Test

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The U.S. Food and Drug Administration this week announced emergency approval to a COVID-19 test developed by Hologic, Inc., a Massachusetts-based medical technology company led by Davidson College alumnus and trustee Steve Macmillan.

The FDA's green light for the test is aimed at dramatically increasing testing capacity for the disease brought on by the outbreak of a novel coronavirus across the globe.

The Emergency Use Authorization authority allows the FDA to fast-track approval during public health emergencies.

“We at Hologic feel incredibly proud to be right on the leading edge of testing breakthroughs that will help lead the world out of this COVID-19 pandemic,” Macmillan said in an announcement by the company, where he is chairman, CEO and president.

Macmillan graduated from Davidson in 1985, and his two-dozen years in the health care industry include nine years leading Stryker Corporation, a global medical device company. He took the helm of Hologic in 2013. The company’s new test detects genetic material from SARS-CoV-2, the new coronavirus strain, in under three hours.

The company said that labs with Hologic's molecular diagnostic platform can process up to 1,150 tests in one day. Hologic plans to provide labs with tens of thousands of tests in March, and will ramp up production in April to around 600,000 tests.

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  • March 18, 2020