Hologic launches automated molecular tests for gastrointestinal bacterial pathogens
Hologic has announced FDA 510(k) clearance and CE marking for its Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays, designed to rapidly detect common bacterial causes of infectious gastroenteritis. The fully automated molecular tests address a significant diagnostic challenge in clinical microbiology laboratories.
Addressing a substantial disease burden
Infectious gastroenteritis represents a considerable public health challenge, with nearly 200 million cases occurring annually in the United States alone, including up to 3 million requiring ambulatory visits. In Europe, foodborne outbreaks have reached their highest hospitalisation and mortality levels in a decade, with Salmonella accounting for the largest proportion of cases.
“At Hologic, we recognise 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, 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.”
Technical capabilities and clinical advantages
The assays detect major bacterial pathogens including Salmonella, Campylobacter, Shigella, E. coli (including O157), Vibrio, Yersinia and Plesiomonas. The tests employ a customisable mini-panel format, allowing clinicians to tailor testing to individual patient presentations rather than running comprehensive panels unnecessarily.
This targeted approach offers several advantages over traditional culture-based methods, which are labour-intensive, time-consuming and less sensitive than molecular techniques. The automated workflow streamlines laboratory processes and accelerates time to diagnosis, supporting antimicrobial stewardship by enabling judicious antibiotic use only when clinically necessary.
Platform integration
Testing is performed on Hologic’s Panther Fusion System, an addition to the company’s fully automated Panther System. The platform consolidates assays for women’s health, sexually transmitted infections, respiratory infections, viral load, transplant viruses and now infectious gastroenteritis, with scalable throughput options for laboratories of varying sizes.
For more information, visit: https://hologic.com/syndromic-testing
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