FDA emergency authorizes Hologic’s coronavirus test
PHOTO | Courtesy of Hologic
The Panther Fusion system from Hologic
A test for the novel coronavirus run on the Panther system from Marlborough medical device manufacturer Hologic has received Emergency Use Authorization from the U.S. Food and Drug Administration.
The Marlborough company announced late Monday the company’s SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, can now be used to test patients under the authorization.
The Panther Fusion system is a fully automated, high-throughput molecular diagnostic platform widely used throughout the United States, according to Hologic. Each Panther Fusion system can provide results on a coronavirus test in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period.
The test is able to be run alongside diagnosis of other common respiratory illnesses. Hologic expects to provide its laboratory customers with tens of thousands of SARS-CoV-2 tests this month as it ramps up production capacity.
Starting in April, Hologic expects to produce nearly 600,000 SARS-CoV-2 tests a month.
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