Cepheid obtained FDA 510(k) clearance for its Xpert GI Panel, a multiplex PCR assay that detects and differentiates 11 gastrointestinal pathogens on GeneXpert systems, positioning the company in the rapid syndromic diagnostics market. The test delivers stool‑to‑answer results in about 74 minutes and leverages Cepheid’s installed instrument base. The clearance moves Cepheid beyond single‑plex assays into mid‑plex syndromic testing and pits the company against established multiplex platforms. Cepheid said the panel aids clinicians in selecting actionable assays across a continuum from single tests to comprehensive panels on a single instrument. The approval could boost near‑patient molecular diagnostics adoption and expand utilization of GeneXpert systems in hospital and community labs.