April 9, 2020

The Aptima SARS-CoV-2 assay combines the industry-leading installed base of Hologic’s Panther instrument with our ability to make millions of the new tests per month. There are more than 1,800 Panther units installed globally – greater than any other high-throughput molecular diagnostic system. Each Panther can provide results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.

In early May, Hologic plans to distribute a Research Use Only (RUO) version of our Aptima SARS-CoV-2 test to hospital, public health and reference labs certified under the Clinical Laboratory Improvement Amendments to perform high complexity tests. These labs can use the assay on the Panther system after completing performance verification testing.

At the same time, Hologic intends to request Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for our new assay and then register a CE Mark certification for the same assay with the European Commission later in the month.

Hologic expects to initially supply 3 million RUO tests. Later in May, we anticipate producing 1 million Aptima SARS-CoV-2 assays per week on average – a substantial increase in the number of coronavirus tests done weekly in the United States, based on data from the COVID Tracking Project. In the coming months, Hologic aims to keep raising production capacity for the new assay.

“Our second COVID-19 test leverages the same proprietary Aptima chemistry and Panther instrumentation that have made Hologic a leader in molecular diagnostics for other infectious diseases,” said Steve MacMillan, Hologic’s chairman, president and CEO. “The ability to deliver test results when and where they are needed – so people can either get back to work or quarantine themselves – has emerged as a key to reopening global economies.”

Importance of testing

Global public health experts recommend robust testing as a long-term solution for dealing with COVID-19. These voices include the World Health Organization, the Association of Public Health Laboratories, Harvard University’s School of Public Health and a partnership between the University of Oxford and the nonprofit group Our World in Data.

In March, Hologic received Emergency Use Authorization from the FDA for our first COVID-19 test, the Panther Fusion SARS-CoV-2 assay. That project included funding support from the Biomedical Advanced Research and Development Authority (BARDA) in Washington, D.C.

“When the COVID-19 pandemic emerged, our initial priority was speed to market, and the Open Access software on the Panther Fusion system allowed us to develop a test within a couple of months,” said Kevin Thornal, president of Diagnostic Solutions at Hologic. “Since then, however, testing needs have grown exponentially, both to control the virus and to help unlock economies. We are proud to have marshalled our human and technological resources, and our massive Aptima production capacity, to bring to market a test that can be implemented more broadly.”

Government agencies, health systems and labs worldwide see the potential for Hologic’s new assay to make a significant impact.

In the United States, BARDA is providing $13 million of advanced development support for the project.

In Europe, numerous countries have decided to use Hologic’s Aptima SARS-CoV-2 assay for their national health systems.

“We have been working closely with government agencies throughout Europe to make plans to provide our Aptima assay,” said Jan Verstreken, Hologic’s regional president for EMEA and Canada. “We believe the Panther system may provide an ideal solution to help labs meet their testing needs during this critical period.”

Public health legacy

Hologic’s contributions to the fight against COVID-19 extend our decades of innovation toward improving public health through early detection.

In 1997, for example, we developed a technology for identifying HIV in blood samples. Today, about 75 percent of the United States’ supply of donated blood is screened for HIV using that breakthrough method. 

Hologic’s HIV detection efforts have expanded to include two molecular assays that run on the Panther system. These tests enable us to serve as a growing source of HIV screening in sub-Saharan Africa, where more than two-thirds of the world’s HIV infections occur.

Other Hologic assays identify pathogens that collectively cause suffering for billions of people worldwide each year, including cervical cancer, sexually transmitted infections and influenza.

“Our purpose at Hologic is to enable healthier lives everywhere, every day, and public health is central to that purpose,” said Thornal, the Diagnostic Solutions president. “Products like our new Aptima assay for coronavirus give us the chance to save many lives – and each of those lives is a grandparent, wife, husband, son or daughter. We’re fortunate to be able to positively affect health at the global and personal levels.”