The PCR test aids in the detection of 11 diarrhea-causing bacteria, viruses, and parasites from one sample.
Cepheid has received US Food and Drug Administration (FDA) clearance for its Xpert GI Panel, a multiplex PCR test that detects 11 gastrointestinal pathogens from a single patient sample.
The test runs on Cepheid’s GeneXpert systems equipped with 10-color modules and simultaneously identifies bacterial, viral, and parasitic pathogens directly from stool specimens in Cary-Blair transport media. The streamlined workflow requires less than one minute of hands-on time and delivers results in approximately 74 minutes.
“The Xpert GI Panel is designed to help healthcare providers identify the cause of infectious diarrhea acquired in the community,” says Dr Connie Savor, chief medical officer at Cepheid, in a release. “By focusing on the most common causative pathogens, we’ve created a panel that balances clinical relevance with operational efficiency.”
Addressing Clinical Need
Gastrointestinal infections affect an estimated 179 million cases of acute gastroenteritis annually in the US. These infections often present with overlapping symptoms such as diarrhea, abdominal pain, and fever that make diagnosis challenging.
Traditional diagnostic methods, such as stool culture, can be time-consuming and labor-intensive, and may miss co-infections or low-abundance pathogens. The multiplex molecular approach allows for simultaneous testing of multiple pathogens, potentially enabling faster clinical decision-making.
Platform Expansion
The new test leverages Cepheid’s 10-color multiplexing technology, expanding the capabilities of existing GeneXpert systems. Labs with systems equipped or upgraded with 10-color modules can now perform broader multiplex testing alongside targeted single-pathogen tests on the same platform.
“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,” says Vitor Rocha, president of Cepheid, in a release.
The Xpert GI Panel complements Cepheid’s existing gastrointestinal testing portfolio, which includes standalone PCR tests for Clostridioides difficile and Norovirus. The test is designed for use in both inpatient and outpatient settings.
The Xpert GI Panel will begin shipping to US customers in the coming weeks.
