Cepheid Receives CE Marking Under IVDR for Xpert® GI Panel

Rhea-AI Summary

Cepheid (NASDAQ:CPHD) announced CE marking under the EU IVDR for its Xpert GI Panel, a multiplex PCR test for 11 gastrointestinal pathogens from one stool sample in Cary-Blair media.

The test runs on 10‑color GeneXpert systems, delivers results in about 74 minutes, and will ship soon to CE-mark countries.

Positive

• CE marking under IVDR for Xpert GI Panel, enabling EU commercial use
• Panel detects 11 GI pathogens from a single stool sample
• Approximate 74‑minute turnaround with under one minute hands‑on time
• Runs on existing GeneXpert systems with 10‑color modules
• Complements existing GI tests for C. difficile and norovirus in Cepheid portfolio
• Planned near‑term shipment to countries accepting the CE mark

Negative

• None.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

IVDR-compliant PCR test supports detection of 11 clinically relevant gastrointestinal pathogens from 1 sample

SUNNYVALE, Calif., May 13, 2026 /PRNewswire/ -- Cepheid, a Danaher company, announced today that it has received CE marking under the in vitro medical device regulation (IVDR) for the Xpert GI Panel. This multiplex PCR test is designed to enable fast, accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample. Leveraging Cepheid's 10-color multiplexing technology on its GeneXpert^® systems, the test offers a robust solution for simplifying GI testing workflows and delivering 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, with results available in approximately 74 minutes.

Patient and Public Health Impact of GI Pathogens
GI infections are a common cause of illness¹ and a leading killer of young children worldwide.² These infections can be caused by a wide range of pathogens including bacteria, viruses, and parasites.³ Diagnosing GI infections can be challenging due to overlapping symptoms such as diarrhea, abdominal pain, and fever.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 like stool culture are often slow and require significant manual effort, with results for specific pathogens typically available in 48 to 72 hours.⁴ These methods may also fail to detect co-infections or pathogens present in low quantities.⁴ In contrast, multiplex molecular testing provides a fast and comprehensive approach by simultaneously testing for multiple pathogens. This equips clinicians to make informed decisions quickly and potentially improves patient outcomes.

"In routine clinical practice, diagnostic tests need to be both clinically relevant and practical for laboratories," said Pr. Valeria Cento, Associate Professor of Microbiology and Clinical Microbiology, Humanitas Research Hospital, Milan, Italy. "Multiplex gastrointestinal panels that combine thoughtful pathogen coverage with a straightforward workflow can support timely decision‑making without adding operational burden."

Multiplex Technology Expands What GeneXpert Systems Can Detect
The Xpert GI panel will run on Cepheid's widely adopted GeneXpert systems equipped or upgraded with 10-color modules, enabling simultaneous detection of 10 or more pathogens or biomarkers.

Expanding Access to High‑Quality Diagnostics
Pursuing CE marking for the Xpert GI panel underscores Cepheid's commitment to improving access to high-quality diagnostics wherever care is needed. It complements Cepheid's existing GI solutions portfolio, which includes standalone PCR tests for Clostridioides difficile and Norovirus.

"CE marking under IVDR for the Xpert GI Panel supports laboratories and clinicians who need diagnostic options that fit different clinical scenarios," said Dr. Connie Savor, Chief Medical Officer, Cepheid. "On the same GeneXpert system and workflow they already use, clinicians can move from single‑pathogen testing, such as C. difficile or norovirus, to broader, syndromic detection when the clinical situation calls for it."

The Xpert GI Panel will begin shipping to countries accepting the CE mark 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.

CE-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. Unicef Data. Diarrhoea. November 2024 https://data.unicef.org/topic/child-health/diarrhoeal-disease/ Accessed April 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. Riddle, MS et al. ACG Clinical Guideline: Diagnosis, Treatment, and Prevention of Acute Diarrheal Infections in Adults. American Journal of Gastroenterology 111(5):p 602-622, May 2016. | DOI: 10.1038/ajg.2016.126

About Cepheid
Cepheid, a Danaher company, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. Cepheid'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.

About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

For Cepheid Media Inquiries: 
media.communications@cepheid.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/cepheid-receives-ce-marking-under-ivdr-for-xpert-gi-panel-302770289.html

SOURCE Cepheid

FAQ

What did Cepheid (CPHD) announce about the Xpert GI Panel on May 13, 2026?

Cepheid announced it received CE marking under IVDR for its Xpert GI Panel. According to Cepheid, this multiplex PCR test detects 11 gastrointestinal pathogens from a single stool sample and will be shipped to countries accepting the CE mark.

What does the Xpert GI Panel from Cepheid (CPHD) test for and how fast are results?

The Xpert GI Panel tests for 11 bacterial, viral, and parasitic GI pathogens. According to Cepheid, it uses multiplex PCR on GeneXpert systems, needs less than one minute of hands‑on time, and provides results in approximately 74 minutes.

On which systems does Cepheid’s Xpert GI Panel (CPHD) run?

The Xpert GI Panel runs on Cepheid GeneXpert systems equipped or upgraded with 10‑color modules. According to Cepheid, this configuration enables simultaneous detection of 10 or more pathogens or biomarkers using the same workflow laboratories already employ.

How does Cepheid’s IVDR‑compliant Xpert GI Panel support GI infection diagnosis?

The Xpert GI Panel offers multiplex molecular testing for multiple GI pathogens in one assay. According to Cepheid, this can simplify laboratory workflows, support faster identification of causative agents, and help clinicians make timely diagnostic decisions compared with traditional stool culture methods.

How does the Xpert GI Panel fit into Cepheid (CPHD) gastrointestinal diagnostics portfolio?

The Xpert GI Panel complements Cepheid’s existing standalone PCR tests for Clostridioides difficile and norovirus. According to Cepheid, clinicians can use the same GeneXpert system to move between single‑pathogen tests and broader syndromic GI detection as clinical scenarios require.

When will Cepheid’s Xpert GI Panel with CE mark be available in Europe?

Cepheid plans to begin shipping the Xpert GI Panel to countries accepting the CE mark in the coming weeks. According to Cepheid, CE marking under IVDR allows laboratories in those markets to adopt the new multiplex GI testing option.