As part of an ongoing collaboration between the US Department of Health and Human Services (HHS) and the US Department of Defense (DOD), the two departments awarded Hologic a $119 million contract to establish additional domestic production to increase diagnostic testing capacity for SARS-CoV-2. This investment will enable Hologic to expand production capacity for covid-19 tests in their suppliers’ facilities in Wisconsin (Baldwin, Hudson, Somerset, and Menomonie), Maine (Guilford), and California (Anaheim, San Diego), increasing their production capacity to 13 million covid-19 tests per month by January 2022.
“Hologic’s platform is in high demand, and with this investment we will be able to improve the supply to laboratories across the country in addition to scaling up employment in Hologic supplier facilities,” says HHS Assistant Secretary for Health ADM Brett Giroir, MD. “Hologic Inc. is now positioned to support the demand for covid-19 testing in the United States due to the installed base of more than 1,100 fully automated, high-throughput Panther and Panther Fusion systems. These Panther systems are each capable of performing more than 1,000 tests in a 24-hour period.”
Hologic has received ongoing support to develop the covid-19 test for these systems from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR). In addition, BARDA is providing funding support for development of the Hologic covid-19 diagnostic tests.
Hologic’s Panther Fusion SARS-CoV-2 Assay and Aptima SARS-CoV-2 Assay received emergency use authorization from the FDA in March 2020 and May 2020, respectively. The tests run on the company’s fully automated Panther Fusion and Panther systems. More than 2,000 of these systems have been installed in clinical diagnostic laboratories around the world, including in all 50 United States.
The unprecedented demand for molecular diagnostic testing driven by the covid-19 pandemic had exceeded Hologic Inc.’s production capacity for sample collection and processing consumables. This investment has been led by the DOD’s Defense Assisted Acquisition (DA2) in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force and funded through the Health Care Enhancement Act to enable and support industrial base expansion for critical medical resources.
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