FDA Clears Rapid Multiplex GI Test That Could Transform Outbreak Detection and Infection Prevention

Rapid identification of gastrointestinal pathogens is a critical but often challenging component of infection prevention, outbreak control, and antimicrobial stewardship. That process may soon become significantly faster and more streamlined following Food and Drug Administration (FDA) of the Cepheid Xpert GI Panel, a multiplex PCR (Polymerase Chain Reaction) test designed to detect 11 clinically relevant bacterial, viral, and parasitic pathogens from a single stool sample.

"The FDA clearance of the Xpert GI Panel continues Cepheid's legacy of innovations intended to make it easier for healthcare professionals to deliver efficient, clinically-relevant care everywhere,” Cepheid president Vitor Rocha told Infection Control Today^®. “With the addition of the Xpert GI Panel to our current offerings, Cepheid is the only company with a continuum of products, from single-target tests to more comprehensive multiplex tests, that run on a single platform and are designed to support providers’ needs for flexibility and efficiency.”

The newly cleared test delivers results in approximately 74 minutes with less than 1 minute of hands-on time, a marked improvement over traditional stool cultures, which can take hours to days and may miss coinfections. For infection prevention and control (IPC) teams, faster and more comprehensive diagnostics can lead to earlier isolation decisions, more targeted treatment, and reduced transmission risk.

Gastrointestinal infections remain a significant public health burden, with an estimated 179 million cases of acute gastroenteritis occurring annually in the US. Because symptoms often overlap across pathogens, delayed or incomplete diagnosis can complicate both patient management and outbreak response in health care and community settings.

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

The test runs on GeneXpert systems equipped with 10-color multiplexing modules, enabling simultaneous detection of multiple pathogens or biomarkers on a single platform. This flexibility may help facilities consolidate testing, reduce send-outs, and support diagnostic-driven antimicrobial stewardship.

For IPC professionals, the availability of rapid, multiplex GI testing offers an opportunity to strengthen surveillance, shorten time to intervention, and limit unnecessary antimicrobial exposure. Cepheid reports the Xpert GI Panel will begin shipping to US customers in the coming weeks, expanding access to high-quality molecular diagnostics across inpatient and outpatient settings.