Hologic has been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to support research and development efforts. This funding will help to bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Aptima SARS-CoV-2 assay in line with the U.S. Food and Drug Administration’s (FDA) in vitro diagnostic (IVD) standards.
Hologic’s Aptima SARS-CoV-2 assay received Emergency Use Authorization (EUA) from the FDA in May 2020. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is currently under development in the United States, while having achieved CE-marking in May 2022 to allow commercialization in the European Union. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a real-time PCR test, while the Aptima SARS-CoV-2 assay utilizes Hologic’s proprietary TMA technology. These tests run on Hologic’s fully automated Panther Fusion and Panther systems, respectively.
This BARDA contract for Hologic will support clinical efforts to obtain claims for nasal samples using the Panther Fusion, as well as full market authorization for COVID-19 testing of asymptomatic individuals who have reason to be tested.
“Hologic has made a significant impact responding to the pandemic by providing millions of highly accurate molecular tests,” says Kevin Thornal, group president, Global Diagnostic Solutions at Hologic. “With the help of our tremendous partners at BARDA, and as the pandemic moves to its next phase, we look forward to transitioning COVID testing from EUA to full market authorization, as well as improving the country’s readiness for future pandemics.”
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50122C00057.
