On Mar. 16, 2020, Hologic announced the U.S. Food and Drug Administration (FDA) had 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.

As previously announced, Hologic was the first company to receive support for coronavirus test development from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

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, representing a 12-fold increase in the Company’s prior manufacturing capacity for similar tests that run on the Panther Fusion system. The Company is also making additional investments to further increase production capacity.

The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low, medium or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access^TM functionality to run laboratory developed tests. Hologic’s Panther and Panther Fusion systems now offer 16 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens. More than 1,800 Panther systems have been installed in clinical diagnostic laboratories around the world, including about 200 Panther Fusion systems.