Hologic’s Molecular Test for SARS-CoV-2 Receives FDA Emergency Use Authorization

Hologic Inc. announced 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.
 
“As one of the largest molecular diagnostic companies in the world, Hologic can make a huge difference in the coronavirus pandemic with our scientific expertise and fully automated, high-throughput testing system,” said Steve MacMillan, chairman, president and CEO of Hologic. “As soon as the outbreak started, our diverse team of scientists and engineers began developing a new, highly accurate test, and we have brought it to market quickly through the FDA’s emergency use process and with assistance from BARDA. Just as we answered calls to help during the H1N1 and Zika virus outbreaks, we are proud to help our laboratory customers and clinicians respond to the urgent public health need for more coronavirus testing.”
 
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).
 
“Making rapid and accurate diagnostic tools available to healthcare providers is critical for early detection and control of COVID-19,” said BARDA Director Rick A. Bright, Ph.D. “The speed at which this assay was developed, validated, and issued EUA—less than two monthsis a testament to Hologic’s commitment to helping reduce the global COVID-19 burden.”
 
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.
 
“Early diagnosis of the coronavirus is critical both to managing infected patients, and to mitigating the spread of the disease,” said Maurice Exner, Vice President of Research and Development and Clinical Affairs at Hologic. “The EUA for our SARS-CoV-2 assay on the Panther Fusion system allows laboratories to run many more tests per day than they can on manual systems, enhancing the public health fight.