FDA Clears Cepheid’s Xpert GI Panel

Cepheid revealed it has gained U.S. Food and Drug Administration (FDA) clearance for Xpert GI Panel, a multiplex PCR test for fast, accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from one patient sample.

It leverages the company’s 10-color multiplexing tech on its GeneXpert systems. The Xpert GI Panel simultaneously detects and identifies 11 important bacterial, viral, and parasitic pathogens from stool specimens in Cary-Blair transport media. The workflow needs less than a minute of hands-on time, providing results in about 74 minutes.

GI infections often present with overlapping symptoms like diarrhea, abdominal pain, and fever that can make diagnosis difficult. Rapid, accurate identification of the causative agent is critical to guide appropriate treatment in high-risk patients and can help reduce risk of outbreaks in healthcare and community settings.

Multiplex testing provides a faster, more comprehensive approach than stool culture by simultaneously testing for multiple pathogens.

“The Xpert GI Panel is designed to help healthcare providers identify the cause of infectious diarrhea acquired in the community,” said Dr. Connie Savor, chief medical officer at Cepheid. “By focusing on the most common causative pathogens, we’ve created a panel that balances clinical relevance with operational efficiency.”

The test runs on Cepheid’s GeneXpert systems equipped or upgraded with 10-color modules that allow simultaneous detection of ten or more pathogens or biomarkers.

“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,” said Vitor Rocha, president of Cepheid.