Cepheid Receives CE Marking Under IVDR for Xpert® GI Panel

IVDR-compliant PCR test supports detection of 11 clinically relevant gastrointestinal pathogens from 1 sample

SUNNYVALE, Calif., May 13, 2026 /PRNewswire/ — 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.

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