MARLBOROUGH, Mass.– Hologic, Inc. (Nasdaq: HOLX) today announced that its Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays have received 510(k) clearance from the U.S. Food and Drug Administration (FDA), along with CE marking under the European Union’s In Vitro Diagnostic Regulation (IVDR). The new fully automated molecular assays are designed to rapidly detect the most common bacterial pathogens that cause infectious gastroenteritis, offering laboratories and clinicians faster, more precise diagnostic tools.
Infectious gastroenteritis, an inflammation of the GI tract caused by bacteria, viruses, or parasites, results in nearly 200 million cases annually in the United States, with millions requiring clinical care. In Europe, foodborne outbreaks have triggered the highest levels of related hospitalizations and deaths in a decade, with Salmonella accounting for the majority of cases. The global burden of diarrheal disease is influenced by multiple factors, including climate change, antibiotic use, agricultural practices, and evolving food safety dynamics.
“At Hologic, we recognize that access to a comprehensive range of accurate and fully automated diagnostic tests is essential for laboratories and their patients,” said Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic. “FDA clearance and CE marking of our first GI pathogen detection tests reflect our dedication to advancing diagnostic innovation, and equipping laboratories and clinicians globally with the tools they need to provide fast and informed care when time matters most.”
Traditional diagnostic methods for severe diarrheal illnesses often involve complex and time-consuming processes like culture, biochemical analysis, and microscopy, which may lack the sensitivity of molecular technologies. Hologic’s Panther Fusion GI Bacterial and Expanded Bacterial Assays use rapid molecular detection to identify major bacterial causes of gastroenteritis, including Salmonella, Campylobacter, Shigella, pathogenic E. coli (including O157), Vibrio, Yersinia, and Plesiomonas. The customizable mini-panel format allows for targeted testing—offering clinicians the flexibility to tailor diagnostics based on individual patient needs, improve lab workflow, and reduce unnecessary testing.
The assays run on Hologic’s Panther Fusion System, a modular extension of the fully automated Panther® platform used in labs worldwide. This scalable system consolidates a wide range of diagnostic tests for women’s health, STIs, respiratory infections, viral load monitoring, and now infectious gastroenteritis. By incorporating GI pathogen testing into its platform, Hologic reinforces its commitment to expanding access to high-quality diagnostics and promoting antimicrobial stewardship through more precise, data-driven treatment decisions.
