Hologic secures emergency authorization for COVID-19 test

2019 08 20 21 43 1377 Hologic Aacc 2019 400

Medical technology company Hologic has garnered U.S. Food and Drug Administration (FDA) emergency use authorization for its Panther Fusion SARS-CoV-2 molecular diagnostic test.

The assay detects SARS-CoV-2, the virus that causes the COVID-19 respiratory disease. With the FDA authorization, Hologic's Panther Fusion automated molecular diagnostic platform can now be used to provide SARS-CoV-2 test results in less than three hours. Up to 1,150 coronavirus tests can be performed in a 24-hour period, according to the vendor.

Healthcare providers can test for SARS-CoV-2 from the same patient sample and collection vial currently used to diagnose other common respiratory viruses whose symptoms overlap with COVID-19, Hologic said.

The company expects to provide laboratory customers with tens of thousands of SARS-CoV-2 tests this month as it ramps up production capacity. By April, nearly 600,000 tests a month are expected to be produced. Hologic also said it's making additional investments to further increase production capacity.

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