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

FDA-cleared PCR test aids in detection  of 11 diarrhea-causing bacteria, viruses, and parasites from 1 sample

SUNNYVALE, Calif., Jan. 20, 2026 /PRNewswire/ -- Cepheid announced today 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.

Patient and Public Health Impact of GI Pathogens
Gastrointestinal infections are a common cause of illness worldwide,^[1] with an estimated incidence of 179 million cases of acute gastroenteritis annually in the United States.^[2] These infections can be caused by a wide range of pathogens—including bacteria, viruses, and parasites—and often present with overlapping symptoms such as diarrhea, abdominal pain, and fever that make diagnosis challenging.^[3] Rapid and accurate identification of the causative agent is critical for guiding appropriate treatment in high-risk patients and can aid in reducing the risk of outbreaks in healthcare and community settings.^[3]

Traditional diagnostic methods, such as stool culture, can be time-consuming, labor-intensive, and may miss co-infections or low-abundance pathogens.^{[4, 5]} Multiplex molecular testing offers a faster, more comprehensive approach by simultaneously testing for multiple pathogens. This equips clinicians to make informed decisions quickly and potentially improves patient outcomes.

"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."

Multiplex Technology Expands What GeneXpert Systems Can Detect
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.

"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.

Expanding Access to High‑Quality Diagnostics
The new Xpert GI panel test underscores Cepheid's commitment to improving access to high-quality diagnostics in both inpatient and outpatient settings. It 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.

References:

1. Wang Y et al., 2023. Global Burden of Digestive Diseases: A Systematic Analysis of the Global Burden of Diseases Study, 1990 to 2019. Gastroenterology, Volume 165, Issue 3, 773 - 783.e15
2. CDC Emerging Infectious Diseases. Volume 28, Number 11, November 2022. Incidence, Etiology, and Healthcare Utilization for Acute Gastroenteritis in the Community, United States. https://wwwnc.cdc.gov/eid/article/28/11/22-0247_article Accessed January 2026.
3. Shane AL et al., 2017. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea, Clinical Infectious Diseases, Volume 65, Issue 12, 15 December 2017, Pages e45–e80, https://doi.org/10.1093/cid/cix669
4. Mehravar S 2023. Diagnostic Tools for Detecting Gastrointestinal Infections. International Foundation for Gastrointestinal Disorders Fact Sheet. https://iffgd.org/wp-content/uploads/280-Diagnostic-tests-for-GI-infections.pdf Accessed January 2026. 
5. Testing.com Medical Review Board. 2021. Gastrointestinal Pathogens Panel. https://www.testing.com/tests/gastrointestinal-pathogens-panel/ Accessed January 2026.

About Cepheid
Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert^® systems and Xpert^® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology, and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

For Cepheid Media Inquiries:
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SOURCE Cepheid