Hologic Receives FDA Clearance and CE Mark for Automated Molecular Tests to Detect Common Causes of Infectious Gastroenteritis

Original from: Hologic

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. 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.

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.

“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.”

Traditionally, identifying pathogens causing severe diarrheal illness required the combination of culture, biochemical and microscopy-based tests, which can be labor-intensive, time-consuming and less sensitive than molecular methods. Hologic’s new GI pathogen detection tests leverage rapid molecular technology and cover common bacterial causes of infectious gastroenteritis, including Salmonella, Campylobacter, Shigella, E. coli (including O157), Vibrio, Yersinia and Plesiomonas, and can be run together or in any combination. In this customizable mini-panel format, the new assays allow testing to be specific and tailored to individual patients’ needs. This approach also helps reduce testing, streamline lab processes and accelerate time to diagnosis and clinical management. In the long term, it supports antimicrobial stewardship by enabling judicious antibiotic use only when clinically necessary.

Testing of the Panther Fusion GI Bacterial and Expanded Bacterial Assays is performed using Hologic’s trusted Panther Fusion System, an add-on to the company’s fully automated Panther® System. This molecular diagnostics platform enables consolidation of a growing menu of assays for women’s health, sexually transmitted infections, respiratory infections, viral load, transplant viruses and now infectious gastroenteritis. Used by laboratories worldwide, the scalable Panther System allows for seamless integration of automated GI pathogen testing and underscores Hologic’s commitment to advancing diagnostic innovation and raising the global standard of care.

Source: Hologic Receives FDA Clearance and CE Mark for Automated Molecular Tests to Detect Common Causes of Infectious Gastroenteritis