Hologic’s molecular test for SARS-CoV-2 receives FDA Emergency Use Authorization

Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Company’s new Panther Fusion® SARS-CoV-2 assay, a molecular diagnostic test that detects SARS-CoV-2, the virus that causes COVID-19 disease.

Hospital, public health and reference laboratories can perform the test on Hologic’s Panther Fusion system, a fully automated, high-throughput molecular diagnostic platform that is widely used across the United States. Each Panther Fusion system can provide results in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period.

Using the Panther Fusion system, healthcare providers can test for SARS-CoV-2 from the same patient sample and collection vial that they currently use to diagnose other common respiratory viruses whose symptoms overlap with COVID-19, boosting efficiency and increasing clinical insight. With a small physical footprint and a broad menu that includes 16 FDA-cleared tests for various infectious diseases, the Panther Fusion system is already widely used in low-, medium- and high-throughput laboratories.

In addition, patient samples can be loaded onto the Panther Fusion system as they arrive in the laboratory, a capability known as random access that improves efficiency and workflow. Overall, the instrument’s high throughput and quick turnaround time will enable more patients to be tested sooner.

Editorial Disclaimer: information published during the 2020 COVID-19 pandemic may be updated frequently to reflect the dynamic nature of current understanding.

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