Cepheid Receives CE Marking Under IVDR for Xpert® GI Panel

Original from: PR Newswire

Cepheid, a Danaher company, announced today that it has received CE marking under the in vitro medical device regulation (IVDR) for the Xpert GI Panel. This multiplex PCR test is designed to enable fast, accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample. Leveraging Cepheid's 10-color multiplexing technology on its GeneXpert® systems, the test offers a robust solution for simplifying GI testing workflows and delivering meaningful answers to clinicians. 

Cepheid's Xpert GI Panel simultaneously detects and identifies 11 important bacterial, viral, and parasitic pathogens directly from stool specimens in Cary-Blair transport media. The streamlined workflow requires less than one minute of hands-on time, with results available in approximately 74 minutes.

Patient and Public Health Impact of GI Pathogens

GI infections are a common cause of illness1 and a leading killer of young children worldwide. These infections can be caused by a wide range of pathogens including bacteria, viruses, and parasites. Diagnosing GI infections can be challenging due to overlapping symptoms such as diarrhea, abdominal pain, and fever. Rapid and accurate identification of the causative agent is critical for guiding appropriate treatment in high-risk patients and can aid in reducing the risk of outbreaks in healthcare and community settings.

Traditional diagnostic methods like stool culture are often slow and require significant manual effort, with results for specific pathogens typically available in 48 to 72 hours.4These methods may also fail to detect co-infections or pathogens present in low quantities.4 In contrast, multiplex molecular testing provides a fast and comprehensive approach by simultaneously testing for multiple pathogens. This equips clinicians to make informed decisions quickly and potentially improves patient outcomes.

"In routine clinical practice, diagnostic tests need to be both clinically relevant and practical for laboratories," said Pr. 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."

Multiplex Technology Expands What GeneXpert Systems Can Detect

The Xpert GI panel will run on Cepheid's widely adopted GeneXpert systems equipped or upgraded with 10-color modules, enabling simultaneous detection of 10 or more pathogens or biomarkers.

Expanding Access to High‑Quality Diagnostics

Pursuing CE marking for the Xpert GI panel underscores Cepheid's commitment to improving access to high-quality diagnostics wherever care is needed. It complements Cepheid's existing GI solutions portfolio, which includes standalone PCR tests for Clostridioides difficile and Norovirus.

"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."

Source: Cepheid Receives CE Marking Under IVDR for Xpert® GI Panel