BARDA expanded an existing partnership with Hologic, Inc., headquartered in Marlborough, Massachusetts, to accelerate development of a new Panther Fusion SARS-CoV-2/Flu/RSV assay for simultaneous detection and differentiation of RNA from the SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) viruses from a single sample.
The Panther Fusion SARS-CoV-2/Flu/RSV assay will run on the Panther system, a fully automated, high-throughput molecular diagnostic platform that is widely used in the U.S. Each Panther system can provide initial results in less than three hours and process more than 1,000 coronavirus tests in a 24-hour period.
This molecular test is the fourth Hologic COVID-19 test to be supported by BARDA; the first was the Panther Fusion SARS-CoV-2 assay which was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on March 16, 2020. The FDA granted an EUA for the Aptima SARS-Cov-2 assay on May 14, 2020 and an EUA for the Aptima SARS-CoV-2/Flu multiplex assay on December 16, 2020.
The SARS-CoV-2 diagnostic tests developed by Hologic, Inc. will increase testing capacity and expand access to testing in the U.S. to more rapidly identify, isolate, and treat patients with COVID-19 as well as those with influenza or RSV.
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Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. Learn more at www.hologic.com.