CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
December 2022—Hologic has been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority. The funding will help bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV and Aptima SARS-CoV-2 assays in line with the FDA’s in vitro diagnostic standards and support clinical efforts to obtain claims for nasal samples using the Panther Fusion as well as market authorization for COVID-19 testing of asymptomatic individuals who have reason to be tested.
The Aptima SARS-CoV-2 assay received EUA in May 2020, and the CE-marked Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is under development in the United States. The project has been funded with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and BARDA.