Automated Molecular Tests Detect Bacterial Pathogens Causing Infectious Gastroenteritis

Infectious gastroenteritis, a common inflammation of the gastrointestinal tract (GI), remains a major public health concern caused by bacterial, viral, or parasitic infections. The disease can range from mild to life-threatening, leading to nearly 200 million cases annually in the U.S., with up to 3 million requiring ambulatory visits. Traditional diagnostic methods for diarrheal illnesses have relied on culture, biochemical, and microscopy-based testing, which are labor-intensive and less sensitive. Now, new automated molecular tests designed to detect common causes of infectious gastroenteritis can deliver tailored, actionable diagnostic results to support fast and informed patient care

Hologic, Inc. (Marlborough, MA, USA) has developed two new automated molecular diagnostic assays, the Panther Fusion Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays, for use on its Panther Fusion System. These tests detect the most common bacterial pathogens responsible for infectious gastroenteritis, providing faster, high-sensitivity results and enabling laboratories to deliver tailored diagnostic insights.

The Panther Fusion assays use advanced molecular technology to identify key bacterial pathogens, including Salmonella, Campylobacter, Shigella, E. coli (including O157), Vibrio, Yersinia, and Plesiomonas. These assays can be performed together or in customizable mini-panels, allowing clinicians to test only for pathogens relevant to the patient’s symptoms, thus reducing unnecessary testing and improving turnaround times.

Testing is performed on the Panther Fusion System, which is an extension of Hologic’s fully automated Panther platform and integrates molecular diagnostics across multiple disease categories. The system supports simultaneous testing for women’s health, respiratory infections, viral load, and transplant viruses. This consolidated platform helps streamline laboratory workflows, maximize efficiency, and minimize manual intervention while delivering precise, rapid results to clinicians.

The Panther Fusion Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays have received FDA 510(k) clearance and CE marking under the European In Vitro Diagnostic Regulation (IVDR). By enabling laboratories to perform customizable and high-throughput molecular testing, the new assays aim to raise global standards for diagnosing GI infections. They not only enhance clinical decision-making but also support antimicrobial stewardship by preventing unnecessary antibiotic prescriptions.

“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, 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.”