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.
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.