Hologic, Inc. announced 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.
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.
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