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Hologic Secures the US FDA’s 510(k) Clearance & European CE Mark for Panther Fusion GI Bacterial Assays to Advance Gastroenteritis Diagnostics

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  • Hologic has received the US FDA’s 510(k) clearance & European IVDR CE Mark approval for its Panther Fusion Gastrointestinal (GI) Bacterial & Expanded Bacterial Assays
  • Panther Fusion GI assays quickly detect key bacterial pathogens causing infectious gastroenteritis, incl. Salmonella, E. coli (incl.O157), Campylobacter, Shigella, Vibrio, Yersinia, & Plesiomonas, using customizable molecular mini-panels to allow faster & more accurate diagnosis, thereby supporting antimicrobial stewardship
  • Tests are run on the fully automated Panther Fusion System, compatible with Hologic’s Panther System, a sample-to-result molecular diagnostics platform used to diagnose a wide range of infectious diseases

Ref: Hologic | Image: Hologic | Press Release

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