Cepheid, a company of Danaher, has received CE marking under the In Vitro Diagnostic Regulation (IVDR) for its Xpert® GI Panel. The multiplex PCR test is designed to rapidly detect 11 gastrointestinal pathogens from a single patient sample.

The test uses Cepheid’s 10-colour multiplexing technology on GeneXpert® systems and is intended to support faster and more accurate gastrointestinal testing while simplifying laboratory workflows.

The Xpert GI Panel can simultaneously identify 11 bacterial, viral and parasitic pathogens directly from stool samples collected in Cary-Blair transport media. The workflow requires less than one minute of hands-on time, with results available in around 74 minutes.

Gastrointestinal infections are a major cause of illness worldwide and remain one of the leading causes of death among young children. Symptoms such as diarrhoea, abdominal pain and fever are common across many GI infections, making diagnosis difficult. Rapid identification of the responsible pathogen is important for selecting suitable treatment and helping to reduce the spread of infection in healthcare and community settings.

Traditional testing methods, including stool culture, can take between 48 and 72 hours and often involve significant manual work. These methods may also miss co-infections or pathogens present in low levels. Multiplex molecular testing allows laboratories to test for multiple pathogens at the same time, helping clinicians make faster treatment decisions.

According to clinical experts, multiplex GI panels with broad pathogen coverage and simple workflows can support timely clinical decision-making without increasing laboratory burden.

The Xpert GI Panel will operate on GeneXpert systems equipped with 10-colour modules, allowing the simultaneous detection of 10 or more pathogens or biomarkers.

Cepheid stated that the approval strengthens access to molecular diagnostic testing and expands its gastrointestinal diagnostics portfolio, which already includes PCR tests for Clostridioides difficile and Norovirus.

The company added that the Xpert GI Panel will begin shipping to countries recognising the CE mark in the coming weeks.

 

Source: prnewswire.com

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