Women's health company Hologic Inc (Nasdaq:HOLX) on Thursday announced US FDA 510(k) clearance and European CE marking for its Panther Fusion Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays.

The assays are designed to rapidly detect common bacterial pathogens causing infectious gastroenteritis, including Salmonella, Campylobacter, Shigella, E. coli, Vibrio, Yersinia, and Plesiomonas.

The tests can be run individually or in combination, allowing labs to tailor diagnostics to patient needs while reducing testing time and streamlining workflows.

Hologic's assays operate on the Panther Fusion System, an add-on to the company's fully automated Panther System, which supports a broad menu of molecular diagnostics. The platform enables faster diagnosis and informed clinical management, and supports antimicrobial stewardship by guiding targeted antibiotic use.

These approvals position Hologic to expand its molecular diagnostic offerings for gastrointestinal infections globally.