Hologic Receives FDA 510(k) Clearance And CE Mark For Panther Fusion Gastrointestinal Bacterial And Expanded Bacterial Assays To Enhance Rapid Diagnosis Of Infectious Gastroenteritis

New Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays deliver tailored, actionable diagnostic results to support fast and informed patient care

Hologic, Inc. (NASDAQ:HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. The company also announced that the assays obtained CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (IVDR). These highly sensitive molecular tests are designed to rapidly detect the most common bacterial pathogens responsible for infectious gastroenteritis.

Infectious gastroenteritis, an inflammation of the GI tract caused by bacteria, viruses or parasites, can range from mild to life threatening. In the United States alone, it is estimated that nearly 200 million cases occur annually, including up to 3 million that require ambulatory visits.1 Across Europe, foodborne outbreaks have resulted in the highest numbers of related hospitalizations and deaths recorded in a decade, with Salmonella accounting for the largest proportion of cases.2, 3

A variety of complex factors, including climate change, agricultural practices, antibiotic use and their respective impacts on the environment and food safety may be contributing to the prevalence of diarrheal disease around the world.3, 4