Cepheid announced that it has received FDA clearance for Xpert GI Panel, a multiplex PCR test designed to provide fast and accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample.
Leveraging Cepheid's advanced 10-color multiplexing technology on its GeneXpert systems, the test offers a robust solution to simplify GI testing workflows and deliver meaningful answers to clinicians.
Cepheid's Xpert GI Panel simultaneously detects and identifies 11 important 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, delivering results in approximately 74 minutes.
The test will run on Cepheid's widely adopted GeneXpert systems equipped or upgraded with 10-color modules that enable simultaneous detection of 10 or more pathogens or biomarkers.
The new Xpert GI panel test complements Cepheid's existing GI solutions portfolio, which includes standalone PCR tests for Clostridioides difficile and Norovirus. The Xpert GI Panel will begin shipping to U.S. customers in the coming weeks.
For more information about the Xpert GI Panel and Cepheid's full menu of molecular diagnostic solutions, visit https://www.cepheid.com.
US-IVD. In Vitro Diagnostic Medical Device.
