Cepheid wins FDA 510(k) for Xpert GI panel – rapid syndromic stool testing

Cepheid secured FDA 510(k) clearance for its Xpert GI Panel, a multiplex PCR assay that detects 11 gastrointestinal pathogens directly from stool in about 74 minutes on GeneXpert systems upgraded to 10‑color technology. The clearance marks Cepheid’s entry into rapid syndromic molecular diagnostics and positions the company to compete with BioMérieux’s BioFire and Qiagen’s mid‑plex offerings. Cepheid emphasized compatibility with its installed base and the clinical utility of a rapid, actionable stool panel in community settings.