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.