Cepheid received CE marking under the EU In Vitro Diagnostic Regulation (IVDR) for its Xpert GI Panel, a syndromic multiplex PCR test for acute gastrointestinal pathogens. The panel detects 11 bacteria, viruses and parasites from a single stool sample with results in about 74 minutes. The assay runs on GeneXpert systems equipped or upgraded with 10-color technology and requires less than one minute of hands-on time. Cepheid said the test supports clinical decisions in overlapping symptom scenarios and can help guide treatment in higher-risk patients. Cepheid also noted the panel’s prior FDA 510(k) clearance earlier this year, and indicated shipping will begin to countries that accept CE marking in the coming weeks.
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