Cepheid has received clearance from the US Food and Drug Administration (FDA) for its Xpert GI Panel, a multiplex polymerase chain reaction (PCR) gastrointestinal (GI) pathogen testing solution.
The panel detects 11 clinically significant bacterial, viral, and parasitic pathogens using a single patient sample on the GeneXpert system, aiming to streamline detection processes for healthcare professionals.
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It identifies pathogens directly from stool specimens collected in Cary-Blair transport media. The workflow is said to require less than one minute of hands-on time and delivers results in 74 minutes.
Traditional diagnostic procedures such as stool cultures are described as labour-intensive and time-consuming, with limitations in detecting co-infections or pathogens present at low levels.
Multiplex molecular testing offers an alternative by enabling simultaneous detection of multiple pathogens, allowing clinicians to make prompt decisions and potentially improve patient management.
The test operates on GeneXpert systems equipped or upgraded with ten colour modules, supporting concurrent detection of over ten pathogens or biomarkers.
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By GlobalDataCepheid president Vitor Rocha said: “Multiplex panels on the GeneXpert system deliver healthcare providers the versatility to do even more for their patients who need answers quickly — from targeted single-pathogen tests to broader multiplex tests on a single platform.”
Cepheid’s chief medical officer Dr Connie Savor said: “The Xpert GI Panel is designed to help healthcare providers identify the cause of infectious diarrhoea acquired in the community. By focusing on the most common causative pathogens, we’ve created a panel that balances clinical relevance with operational efficiency.”
In August 2025, Health Canada granted a medical device licence for Cepheid’s Xpert HCV VL Fingerstick, a test used to detect and quantify the hepatitis C virus (HCV) from a single blood drop.
