MARLBOROUGH, Mass.--Hologic, Inc. (Nasdaq: HOLX) announced today that it 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 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.
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.
About the Panther and Panther Fusion Systems
The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection and viral load testing, which can all be done simultaneously. The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory-developed tests.
About Hologic, Inc.
Hologic, Inc. is a global medical technology innovator primarily focused on improving women’s health and well-being through early detection and treatment. Its advancements include invention of the world’s first commercial 3D mammography system to fight breast cancer; leadership in testing for cervical cancer, sexually transmitted infections, respiratory illnesses, and the virus that causes COVID-19; and minimally invasive surgical technologies for uterine fibroids and abnormal uterine bleeding.
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Post time: Nov-25-2022