Hologic Gains FDA Clearance for First GI Pathogen Detection Assays
Hologic has secured FDA clearance for its Panther Fusion GI Bacterial and Expanded Bacterial Assays, marking the company’s entry into the gastrointestinal testing market. The assays, which also recently received a CE mark in Europe, detect leading bacterial causes of infectious gastroenteritis such as Salmonella, Campylobacter, Shigella, Vibrio, Yersinia, Plesiomonas, and E. coli.
Unlike traditional biochemical and microscopy-based methods, the assays allow tests to be run individually or in combination, reducing labor and time demands in identifying pathogens that cause diarrheal disease. Globally, nearly 200 million gastroenteritis cases occur each year, with up to three million requiring medical visits.
The launch follows Hologic’s $159 million acquisition of Diagenode in 2021, which added more than 30 proprietary PCR tests to its portfolio. Hologic joins competitors like Qiagen, which recently gained clearance for its QIAstat-Dx GI Panel 2 Mini B&V.
02-10-2025
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