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Cepheid Wins IVDR CE Mark for Multiplex GI Panel, Expanding GeneXpert Menu in Europe

Cepheid Wins IVDR CE Mark for Multiplex GI Panel, Expanding GeneXpert Menu in Europe

New updates have been reported about Cepheid.

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Cepheid has secured CE marking under the EU’s in vitro diagnostic regulation for its Xpert GI Panel, positioning the company to deepen penetration of its GeneXpert installed base in markets that accept the CE mark. The cartridge-based multiplex PCR assay detects 11 key gastrointestinal pathogens from a single stool sample in about 74 minutes with under one minute of hands-on time, aiming to replace slower and more labor-intensive culture-based workflows.

Running on GeneXpert systems configured with Cepheid’s 10-color modules, the new panel broadens the platform’s syndromic testing capabilities and complements existing single-pathogen GI assays such as Clostridioides difficile and norovirus. By enabling clinicians to flex between targeted and broad GI testing on the same platform and workflow, Cepheid is likely to increase testing throughput per instrument, support higher utilization of its recurring consumables model, and strengthen its competitive position in molecular GI diagnostics as shipments to CE-mark countries begin in the coming weeks.

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