Hologic Earns FDA, EU Nods for Infectious Gastroenteritis Tests

Hologic has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Panther Fusion gastrointestinal (GI) bacterial and expanded bacterial assays. The company also received CE mark approval for the assays.

These molecular tests were designed to quickly 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. Traditionally, identifying pathogens causing severe diarrheal illness required combining culture, biochemical, and microscopy-based tests, which can be labor-intensive, time-consuming, and less sensitive than molecular methods.

Hologic’s new tests use 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.

The customizable mini-panel format for the assays let testing be specific and tailored to patients’ needs. This approach helps reduce testing, streamline lab processes, and speed time to diagnosis and clinical management.

Testing of the Panther Fusion GI bacterial and expanded bacterial assays is performed using Hologic’s Panther Fusion system, an add-on to the company’s fully automated Panther system.

“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.”

In June, the company was welcomes to The National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium (MDIC). The appointment reflects Hologic’s commitment to advancing the use of real-world data (RWD) to support medical device evaluation and drive innovation in women’s health.