Cepheid Receives FDA Clearance for Xpert GI Panel to Support Broad Detection of GI Pathogens

Molecular diagnostics company Cepheid has announced the FDA clearance for its Xpert GI Panel, a next-generation multiplex PCR test that delivers fast, accurate detection of a comprehensive range of gastrointestinal (GI) pathogens from a single patient specimen.

Designed to run on Cepheid’s established GeneXpert systems, the new panel can simultaneously identify 11 clinically relevant diarrhea-causing bacteria, viruses and parasites directly from stool samples. 

The streamlined workflow requires less than one minute of hands-on time and delivers results in about 74 minutes, a dramatic reduction compared with traditional diagnostics.

GI infections remain one of the most common causes of acute illness globally and in the US, with tens of millions of cases reported annually. According to the CDC, there are an estimated 179 million cases of acute gastroenteritis annually in the US.

Symptoms such as diarrhea, abdominal pain, nausea and fever are common, but can be caused by many different pathogens, making rapid, accurate diagnosis essential for effective patient care and public health response.

Conventional stool culture and targeted assays can take days to return results and may miss co-infections or low-abundance organisms. By contrast, the Xpert GI Panel’s multiplex PCR technology detects multiple pathogens at once, helping clinicians quickly pinpoint the causative agent, guide appropriate treatment decisions and improve infection control.

Cepheid explains that the new panel utilizes the company’s 10-color multiplexing capability, allowing GeneXpert systems equipped with upgraded modules to detect ten or more target sequences in a single run. This expanded capacity adds flexibility for laboratories that already use GeneXpert instruments for a broad menu of molecular diagnostics.

“The Xpert GI Panel is designed to help healthcare providers identify the cause of infectious diarrhea acquired in the community,” said Cepheid chief medical officer Dr. Connie Savor. 

“By focusing on the most common causative pathogens, we’ve created a panel that balances clinical relevance with operational efficiency.”

The panel focuses on pathogens of high clinical relevance while optimizing operational efficiency in busy labs and clinical settings.

Cepheid plans to begin shipping the Xpert GI Panel to US customers in the coming weeks. 

The test complements the company’s existing GI diagnostics portfolio, which includes standalone assays for pathogens such as C. difficile and norovirus, broadening clinicians’ ability to evaluate GI infections with molecular precision.