 clearance for Hologic’s Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.){kind=link}
The U.S. Food and Drug Administration has granted 510(k) clearance for Hologic’s Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. In parallel, the assays have received CE marking under the European Union’s In Vitro Diagnostic Regulation. These approvals permit broader clinical adoption of the molecular tests across the United States and Europe.
The assays are designed for the rapid detection of bacterial pathogens commonly associated with infectious gastroenteritis, a condition characterized by inflammation of the gastrointestinal tract and attributable to bacterial, viral, or parasitic agents. Infectious gastroenteritis remains a significant global health burden. In the United States, estimates suggest nearly 200 million cases annually, with approximately 3 million requiring ambulatory care. Across Europe, surveillance data indicate a decade-high incidence of foodborne outbreaks, with Salmonella identified as a leading contributor to hospitalizations and mortality.
At Hologic, we recognize that access to a comprehensive range of accurate and fully automated diagnostic tests is essential for laboratories and their patients. 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.
Jennifer Schneiders, Ph.D., President, Diagnostic Solutions at Hologic
Multiple environmental and societal factors, including climate change, shifts in agricultural practices, and antibiotic use are thought to influence the epidemiology of diarrheal diseases by altering microbial ecology and food safety dynamics. Traditional diagnostic workflows for severe bacterial gastroenteritis have historically relied on culture, biochemical assays, and microscopy. While effective, these methods are often time-intensive, resource-demanding, and can exhibit reduced sensitivity relative to molecular technologies.
The Panther Fusion GI Bacterial and Expanded Bacterial Assays employ nucleic acid amplification to detect a range of clinically relevant bacterial pathogens, including Salmonella, Campylobacter, Shigella, Escherichia coli (including O157), Vibrio, Yersinia, and Plesiomonas. Importantly, the assays can be run individually or in combination, offering a customizable mini-panel approach. This modularity enables laboratories to tailor testing strategies to specific clinical scenarios, with potential downstream benefits in efficiency, diagnostic turnaround time, and antimicrobial stewardship.
Both assays are compatible with Hologic’s Panther Fusion System, an extension of the fully automated Panther® platform. This system currently supports a broad diagnostic menu spanning women’s health, sexually transmitted infections, respiratory pathogens, viral load monitoring, and transplant-related viruses. The addition of gastrointestinal pathogen testing further expands its syndromic testing capabilities, aligning with ongoing efforts to consolidate laboratory workflows and enhance clinical decision-making.