MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that it has been awarded a $119 million contract from the United States government to expand its production capacity for COVID-19 molecular tests. The contract will support capital and labor investments enabling Hologic to provide 13 million COVID-19 tests per month for the U.S. market by January of 2022.
Hologic’s Panther Fusion® SARS-CoV-2 Assay and Aptima® SARS-CoV-2 Assay received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration in March 2020 and May 2020, respectively. The tests run on the Company’s fully automated Panther Fusion® and Panther® systems, which provide initial results in approximately three hours and process more than 1,000 tests in 24 hours. More than 2,000 of these systems have been installed in clinical diagnostic laboratories around the world, including in all 50 U.S. states.
“Hologic has already made significant investments in our test production capacity, which have resulted in our contributing tens of millions of COVID tests to the United States supply,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “Our manufacturing teams continue to innovate to increase our contribution, and we are very pleased to partner with the federal government to further our ability to meet the ongoing public health need.”
The Department of Defense Joint Rapid Acquisition Cell collaborated with the Department of the Air Force’s Acquisition COVID-19 Task Force and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, to award the contract with BARDA funding. BARDA is also separately supporting development of Hologic’s COVID-19 assays.
About the Panther and Panther Fusion Systems
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 infections and viral testing, which can all be done simultaneously. In addition, patient samples can be loaded onto the Panther 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 enable more patients to get results sooner.
The Panther Fusion system adds PCR (polymerase chain reaction) chemistry and provides an expanded in vitro diagnostics menu, as well as Open Access functionality to run laboratory developed tests. Together, the Panther and Panther Fusion systems now offer 16 FDA-cleared assays and 20 CE-marked assays that detect more than 20 pathogens.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.
This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s Panther Fusion and Panther systems, and the Panther Fusion SARS-CoV-2 and Aptima SARS-CoV-2 Assays. There can be no assurance these products will receive full market authorization, achieve the benefits described herein, or be scaled up successfully. In addition, there can be no assurance that these products will be manufactured in adequate quantities to meet demand, be commercially successful, or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.
Hologic, Aptima, Panther, Panther Fusion and The Science of Sure are registered trademarks of Hologic, Inc. in the United States and/or other countries.
SOURCE: Hologic, Inc.