On Nov. 2, 2022, Hologic announced that it had been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to support research and development efforts. This funding helped 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ﾒs in vitro diagnostic 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 was 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 supported 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.