Cepheid received 510(k) clearance for its Xpert GI Panel, a rapid multiplex PCR assay that detects and distinguishes 11 gastrointestinal pathogens from stool in about 74 minutes on GeneXpert systems upgraded with 10‑color technology. The clearance positions Cepheid in the syndromic molecular diagnostics market alongside BioMérieux’s FilmArray and Qiagen’s QiaStat‑Dx. Cepheid described the panel as clinically focused on actionable community‑acquired diarrhea pathogens and said it expands instrument utility for labs that already run single‑plex assays on GeneXpert. The move broadens the company’s test menu and may influence purchasing decisions among labs with installed GeneXpert capacity.
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