The FDA has cleared the Xpert GI Panel from Cepheid, a multiplex PCR test that detects 11 gastrointestinal pathogens from a single stool sample in just over an hour.
The panel identifies eight bacteria, two parasites, and one virus commonly responsible for diarrheal syndromes acquired outside hospital settings. The test runs on Cepheid’s GeneXpert platform and can simultaneously detect multiple pathogens using a 10-color module.
Traditional microbiology testing for diarrheal illnesses often requires multiple cultures and can take several days, sometimes missing coinfections or low-abundance pathogens. With an estimated 179 million cases of acute gastroenteritis occurring annually in the U.S., faster diagnostics could help clinicians quickly identify the cause of infection, guide treatment decisions, and reduce the spread of pathogens in healthcare and community settings.