Get fast and accurate PCR results, virtually anywhere.
Cepheid’s menu of more than 20 FDA-cleared and emergency-use authorized tests run on the GeneXpert® family of systems to provide accurate, high-quality real-time PCR results when and where you need them most.
Improving the quality of healthcare with PCRplus testing
Cepheid's tests can enable improved clinical outcomes, operational efficiencies, and patient experience across the continuum of care. That's the PCRplus advantage.
The GeneXpert® family of systems is standardized yet scalable across the healthcare continuum — from hospital labs to emergency departments, pediatric and primary care settings.
#1 Most popular sample-to-answer PCR system^
#1 Largest PCR testing on a single IVD instrument#
#1 Customer Experience in Clinical Diagnostics†
#1 Best Service, Best System Performance‡
The GeneXpert Xpress is a game changer and will save many lives, and I can't thank you enough for giving us a chance to make a difference in the lives of our patients and local economy.
Cepheid test menu
With more than 20 FDA-cleared or authorized tests (including moderate complexity and CLIA waived tests), Cepheid is the ideal real-time PCR diagnostic partner for improved clinical decision-making and optimized patient care.
- Xpert Xpress CoV-2 plus§ - A rapid, near-patient test for the SARS-CoV-2 respiratory virus detection, including emerging variants, to provide timely, effective triage**
- Xpert Xpress CoV-2/Flu/RSV plus§- Actionable, rapid respiratory results to meet the challenges of the ongoing pandemic**
- Xpert Xpress Flu** - Accurate and reliable detection of Flu A and Flu B, in as soon as 20 minutes^^
- Xpert Xpress Strep A** - Qualitative real-time PCR test providing accurate detection of Group A Streptococcus in as soon as 18 minutes^^
HAI & Other Infectious Diseases
- Xpert Carba-R - qualitative, on-demand, real-time PCR test for the detection and differentiation of KPC, NDM, VIM, OXA-48, and IMP in 50 minutes
- Xpert C. difficile - Detection of Clostridium difficile in as soon as 40 minutes^^
- Xpert C. difficile/Epi - 45-minute detection & differentiation of Clostridium difficile and the Epidemic 027 strain
- Xpert® EV - Fast molecular in vitro diagnostic enteroviral meningitis test
- Xpert MRSA/SA Blood Culture - Accurate detection of Staphylococcus aureus (SA) and MRSA in positive blood culture specimens in about an hour
- Xpert MRSA/SA SSTI – Detection of MRSA & SA skin and soft tissue infections in about one hour from nasal swabs
- Xpert MRSA NxG - Accurate, fast, on-demand PCR test that detects Methicillin-resistant Staphylococcus aureus (MRSA) directly from nasal swabs
- Xpert Norovirus - Rapid identification and differentiation of Norovirus GI and GII in less than one hour^^
- Xpert SA Nasal Complete - detection of S. aureus and MRSA in about an hour
- Xpert vanA - Rapid and accurate test to assist with VRE surveillance
Women's Health & Sexual Health
- Xpert CT/NG - 90-minute detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)
- Xpert GBS - Direct intrapartum group B strep results within an hour for labor/delivery
- Xpert GBS LB XC - On-demand antepartum group B strep PCR screening test from lim broth
- Xpert Xpress MVP - On-demand PCR test to aid in the diagnosis of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis in symptomatic women from a single swab within an hour
- Xpert TV - Fast and accurate diagnosis of trichomoniasis for both women and men in about 42 minutes^^
TB & Emerging Infectious Diseases
- Xpert Ebola§ - Detection of Ebola Zaire virus in around 90 minutes
- Xpert Mpox§ - On-demand Mpox testing provides accurate point-of-care results in approximately 36 minutes
- Xpert MTB/RIF - Accurate detection of MTB and Rifampin resistance mutations
Oncology & Human Genetics
- Xpert BCR-ABL Ultra - Sensitive and quantitative monitoring of BCR-ABL mRNA in patients with chronic myelogenous leukemia (CML)
- Xpert FII & FV - 30-minute test for genetic risk of thrombosis
- Xpert NPM1 Mutation - Quantitative assay of the NPM1 mRNA transcripts (Type A, B, and D) and the ABL1 endogenous control mRNA transcript in EDTA peripheral blood samples. For Research Use Only (RUO)
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Frequently Asked Questions (FAQ)
The GeneXpert and GeneXpert Infinity Systems are available in 2 to 80 modules to meet your lab capacity testing needs and can run our entire menu of tests. Cepheid's GeneXpert Xpress utilizes the same cartridge and module technology in a point of care system designed for near-patient healthcare settings capable of running our CLIA-waived respiratory testing menu.
The GeneXpert family of systems offers:
- Fully automated sample extraction, PCR amplification, and detection
- Simple workflow with minimal hands-on time and walk away capabilities for unparalleled efficiency
- Fast and accurate PCR results, with most test results in less than one hour
- Laboratory information system (LIS) and electronic medical record (EMR) interface capabilities
- Compact and scalable design options to grow with your testing needs
- Closed cartridge technology reduces the risk of contamination and enables random-access, mix-and-match testing capabilities for optimal flexibility.
Learn more about our cartridge technology here
The PCRplus advantage delivers a higher level of PCR excellence by bringing together:
- Accurate results that clinicians and patients can rely on.
- Speed and efficiency to deliver on-demand answers WHEN they are needed most.
- A flexible delivery platform - like the GeneXpert® system and Xpert® test cartridges that can deliver those results WHERE they are needed, from the lab to the point of care.
- Quality of test design - a proven track record of delivering quality across a broad menu of test products. Experience matters.
- Simplicity - a solution that is easy to learn, adopt, and operate across a variety of settings and users.
GeneXpert Systems are available in a two, four, 16, 48, or 80-module configuration. In addition, our CLIA-Waived GeneXpert Xpress is available for front line access and control, anywhere you need it. All GeneXpert Systems have our proven GeneXpert module at their analytic heart, and use the same patented cartridge technology for every Xpert test.
Cepheid's GeneXpert Xpress is an efficient, streamlined, and scalable workflow solution that delivers CLIA waived molecular results. The GeneXpert Xpress system produces quality results without any specialized training or daily or weekly maintenance. It’s a true walk-away system with short sample prep time that will provide faster results before your patients even leave your facility.
US-IVD. In Vitro Diagnostic Medical Device.
* Turnaround times vary by test. See individual Package Inserts for specific turnaround times
^ GeneXpert® Systems - largest worldwide installed base for a single sample-to-answer PCR-based testing system. Cepheid internal data, 2022
# Largest number of cleared US-IVD tests running on a single platform. IVD nucleic acid testing market analysis, 2021
† Clinical Diagnostics Customer Experience research, US, Canada, and Europe, 2020. Data on file.
‡ 2020 IMV ServiceTrak™ Clinical Laboratory Awards in Molecular Diagnostics
§ These tests have not been FDA cleared or approved. These tests have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. Xpert Xpress CoV-2 plus has been authorized only for the detection of nucleic acids from SARS-CoV-2, and not for any other viruses or pathogens. Xpert Xpress CoV-2/Flu/RSV plus has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens. Xpert Mpox has been authorized only for the detection of nucleic acid from monkeypox virus or other non-variola orthopoxviruses, not for any other viruses or pathogens. Xpert Ebloa has been authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014). The emergency use of these products is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19, monkeypox virus, including non-variola Orthopoxvirus, and/or Ebola virus under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
** In vitro diagnostic device for use in Moderate Complexity or CLIA waived settings.
^^ With early assay termination (EAT) for positive results. Full tests runtimes are as follows: Xpert Xpress Flu is 30 minutes, Xpert Xpress CoV-2 plus is approximately 30 minutes, Xpert Xpress Strep A is 24 minutes, Xpert TV is 70 minutes, Xpert C. difficile is 43 minutes. With early assay termination for positives when running SARS-CoV-2 only on Xpert Xpress CoV-2/Flu/RSV plus full run time is 36 min. Xpert Norovirus is 88 minutes
1. Gaydos C, et al. Use of a Rapid Diagnostic for Chlamydia trachomatis and Neisseria gonorrhoeae for Women in the Emergency Department Can Improve Clinical Management: Report of a Randomized Clinical Trial. Ann Emerg Med. Sept 2018.