Hologic gains FDA clearance for GI pathogen detection assays

Hologic’s FDA clearance for its Panther Fusion GI Bacterial and Expanded Bacterial Assays represents the company’s entry into the gastroenteritis test market.

The US Food and Drug Administration (FDA) has cleared Hologic’s first gastrointestinal (GI) pathogen detection tests.

The FDA clearance for the Panther Fusion GI Bacterial and Expanded Bacterial Assays coincides with the tests’ receipt of a CE mark in Europe.

The US-based company’s new GI pathogen detection tests cover common bacterial causes of infectious gastroenteritis, including Salmonella, Campylobacter, Shigella, E. coli, Vibrio, Yersinia and Plesiomonas.

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