Cepheid Wins IVDR CE Mark for Xpert GI Panel

Cepheid, a Danaher company, has received CE marking under the in vitro diagnostic regulation (IVDR) for its Xpert GI Panel, a multiplex PCR test designed to detect 11 clinically relevant gastrointestinal pathogens from a single stool sample. Announced on 13 May 2026, the approval clears the test for commercial use across CE-mark accepting markets and broadens Cepheid’s syndromic testing footprint on its widely deployed GeneXpert platform.

The Xpert GI Panel detects bacterial, viral and parasitic pathogens directly from stool specimens in Cary-Blair transport media. The workflow requires under a minute of hands-on time, with results available in approximately 74 minutes. That sits well below the 48 to 72 hours typically associated with traditional stool culture methods, which can also miss co-infections or pathogens present in low quantities. The test runs on GeneXpert systems equipped or upgraded with 10-colour modules, enabling simultaneous detection of 10 or more targets in a single run.

Dr Connie Savor, Cepheid’s Chief Medical Officer, said the CE mark allows laboratories and clinicians to move between single-pathogen testing, such as Clostridioides difficile or norovirus, and broader syndromic detection on the same instrument and workflow they already use. Professor Valeria Cento of Humanitas Research Hospital in Milan added that multiplex panels combining clinically relevant pathogen coverage with a straightforward workflow can support timely decision-making without adding operational burden. Shipping to CE-mark accepting countries is expected within weeks.

The CE mark positions Xpert GI Panel as a syndromic complement to Cepheid’s existing standalone C. difficile and norovirus assays, giving European labs more flexibility on the GeneXpert estate they already run. Expect competitive pressure to rise across the GI syndromic testing category, where speed, pathogen coverage and operational simplicity are increasingly the deciding factors for laboratory procurement.