Rapid Multiplex PCR Test Detects 11 Gastrointestinal Pathogens from Single Sample

Cepheid’s Xpert GI Panel has received CE marking under the In Vitro Diagnostic Medical Devices Regulation (IVDR) and is expected to begin shipping to countries that accept the CE mark in the coming weeks. Designed for fast, accurate detection of 11 clinically relevant gastrointestinal pathogens from a single patient sample, the assay runs on GeneXpert systems using 10-color multiplexing technology to analyze multiple targets in one reaction.

From stool specimens collected in Cary-Blair transport media, the test detects and identifies bacterial, viral, and parasitic pathogens. The streamlined workflow requires less than one minute of hands-on time and delivers results in about 74 minutes.

Gastrointestinal infections often present with overlapping symptoms, making timely identification difficult. Conventional stool culture can take 48 to 72 hours and may miss co-infections or low-level pathogens, creating clinical and operational challenges. Multiplex molecular testing offers a fast, comprehensive alternative to culture-based methods while fitting a range of clinical scenarios.

The new panel complements existing single-pathogen Xpert assays for Clostridioides difficile and norovirus, allowing laboratories to tailor test selection to patient presentation on the same platform. GeneXpert systems equipped or upgraded with 10-color modules can support simultaneous detection of 10 or more pathogens or biomarkers.

“In routine clinical practice, diagnostic tests need to be both clinically relevant and practical for laboratories,” said Prof. Valeria Cento, Associate Professor of Microbiology and Clinical Microbiology, Humanitas Research Hospital, Milan, Italy. “Multiplex gastrointestinal panels that combine thoughtful pathogen coverage with a straightforward workflow can support timely decision‑making without adding operational burden.”

“CE marking under IVDR for the Xpert GI Panel supports laboratories and clinicians who need diagnostic options that fit different clinical scenarios,” said Dr. Connie Savor, Chief Medical Officer, Cepheid. “On the same GeneXpert system and workflow they already use, clinicians can move from single‑pathogen testing, such as C. difficile or norovirus, to broader, syndromic detection when the clinical situation calls for it.”