GeneXpert:

The worlds only

fully-integrated
real-time PCR system

Samples become answers.

Delivering on the promise of molecular

analysis through sample in, answer out
integrated genetic testing.

The advent of molecular analysis technology, and the resulting mapping of the human genome, have
given powerful new tools to scientists, medical researchers and public health ofcials to help protect,
prolong and improve the quality of life. However, the potential of molecular analysis has not been fully
achieved. Slow, labor-intensive methods have conned genetic assessment to large and expensive
specialty laboratories run by highly trained technicians. As a result, many of the most promising
applications of genetic assessment have yet to be realized.
Now, due to the introduction of the GeneXpert System by Cepheid, these barriers are being
eliminated. GeneXpert is the worlds rst and only genetic testing platform to perform real- time
analysis of biological samples by fully integrating and automating what have previously been complex
and time-consuming manual laboratory procedures.
The GeneXperts ability to rapidly and accurately identify a wide range of diseases and agents through
their genetic ngerprint will give health care professionals powerful new ways to enhance patient
management and care. And it will provide powerful tools for rst-responders to combat the spread
of infectious diseases and reduce the dangers of bioterrorism. With a level of sensitivity that may
be greater than any other system, the GeneXpert can be used to detect any genetic element in the
genome including DNA, RNA, chromosomal translocations, gene amplication and suppression
with the potential for single cell detection. Its accuracy and ease-of-use has been extensively
validated by a U.S. government interagency working group and by third-party university and private
research labs.
With its revolutionary sample in, answer out simplicity, the GeneXpert System is ready to deliver
real-time genetic analysis wherever and whenever it is needed.

The GeneXpert System fully integrates

and automates the three processes required
for real-time PCR-based genetic testing:
sample prep, amplication, and detection.
Once a biological sample is loaded
in a GeneXpert cartridge, the system
does the rest:

Sample preparation and extraction of nucleic acids.

The GeneXpert System completely automates sample preparation, performing all the complex steps
of DNA extraction in its advanced microuidic cartridges. The GeneXpert cartridges are designed to
handle a variety of sample volumes, enabling them to obtain higher concentrations of starting target
materials. Concentration and purication of the target further increases the sensitivity of the resulting test. Once the sample nucleic acid is extracted, it is moved into the cartridge reaction tube where
amplication and detection take place.

Amplication of extracted nucleic acids.

The GeneXpert System modules perform the extremely rapid heating and cooling cycles required
for highly accurate, real time PCR. The modules continuously monitor the chemical reactions in
each cartridge in order to quickly create enough copies of the sample nucleic acid for accurate
measurement. Each of the modules works independently and can be used to conduct different
tests simultaneously.

Detection of a target gene sequence.

The GeneXpert Systems highly sensitive optics detect the presence of the target nucleic acid. Continuous optical monitoring allows the software to automatically stop the reaction as soon as the target is
detected, further accelerating time to results.

GeneXpert Module:
Processing Unit:

For higher throughput, systems with up to 16 modules can be congured.

One GeneXpert processing unit can have one, two, or four modules.

Each module can provide four answers.

GeneXpert Cartridge:
The cornerstone of the GeneXpert testing process are Cepheids patented, self-contained, single use cartridges.

processing chambers
contain reagents, lters, and capture technologies
necessary to extract, purify, and amplify target nucleic acids

optical windows
enable real time optical detection

reaction tube
thin chamber enables very rapid thermal cycling

valve
enables uid transfer from chamber to chamber,
may contain nucleic acids lysis and ltration components

Self-contained, single use cartridges

The GeneXpert System is the worlds rst and only real-time PCR instrument which combines fully
integrated sample prep with the amplication and detection process. The cornerstone of the GeneXpert
testing processes are Cepheids patented, self-contained, single use cartridges. This ground-breaking
technology allows laboratory and non-laboratory personnel to conduct sophisticated molecular-based
testing in a wide range of environments including hospitals, research laboratories, physician ofces,
public health clinics or corporate settings.
Most DNA analysis and detection procedures start with DNA that has been extracted or removed from
the sample. In many cases, samples are complex in composition (whole blood, human cells or tissue,
swabs) and the associated sample preparation protocols are complex and time-consuming. In addition,
many real world applications involve detection of a very small number of pathogens or target genes in
a large volume of sample. Cepheids cartridges are designed to handle a variety of volumes, which provides the ability to obtain higher concentrations of starting target materials in the cartridge.

The GeneXpert Module

A GeneXpert module is a complete, independent,
temperature-controlled uorimeter for performing and continuously monitoring chemical reactions such as real-time PCR.
The temperature of the sample can be controlled rapidly and
precisely, allowing faster reactions and more accurate results.
Cepheids technology allows sample analysis to be performed
using much less power than traditional methods. This permits
our systems to be truly portable, giving our customers the
capability to obtain bioanalytical results when and where they
are needed.

fan
cooling cycle
optical blocks
optical analysis, detect and
quantify up to four different
nucleic acid targets simultaneously

circuitry
passes optical information
to computer for analysis
and display

Each module includes a four-channel optics system capable

of exciting and detecting multiple uorescent dyes in the same
reaction tube. Continuous optical monitoring during amplication also allows the software to automatically stop the
reaction as soon as the target is detected, shortening the time
to results.

genexpert cartridge
sample preparation

heating plates
heating cycle

ta
tio
ex
ci

io

ct
te

the genexpert microuidic cartridge

de

Each unit is operated and controlled independently. In contrast

to traditional thermal cycling systems, in which all samples
are subjected to the same time/temperature/optical protocol,
each sample in a GeneXpert System can be subjected to
a different protocol.

Why the GeneXpert System?

The GeneXpert System is the only to combine sample preparation with real time PCR amplication and detection functions
for fully integrated and automated nucleic acid analysis. The system puries, concentrates, detects, and identies targeted nucleic acid
sequences, delivering answers from unprocessed samples in as little as 30 minutes. This easy-to-use system is ideal for time critical
applications in clinical genetic assessment, life sciences and biothreat applications. Current techniques for accomplishing the
same complex series of sample prep and PCR procedures requires extensive manual labor by skilled technicians that can take upwards
of 8 hours.

expert: by design
integrated:
Combines sample prep, amplication and real-time detection.
The GeneXpert System integrates the entire genetic identication
process, requiring little operator handling or specialized knowledge.
Users simply insert the biological sample for testing into a selfcontained cartridge, and the GeneXpert System does the rest. No
laboratory facilities or laboratory training for operators is required.
When testing is complete, the system will display a positive or
negative answer for the presence of the targeted nucleic acid
sequences.

An expanding pipeline of genetic tests:

While the GeneXpert System has potential applications in a wide spectrum of industries, Cepheid is focused on providing integrated testing
solutions in three markets clinical genetic assessment, biothreat,
and life sciences which have the greatest current needs and growth
potential. Off the shelf, fully integrated gene-specic tests currently
under development include ones to assist in the research and detection
of Group B Streptococcus, Enterovirus, leukemia, breast cancer, and
melanoma. Also in the pipeline are tests to detect the etiologic agents
of anthrax, plague and tularemia in a single GeneXpert test cartridge.

comprehensive:
Works with many types of raw environmental and human
specimens. GeneXpert cartridges accept virtually any kind of
airborne, liquid or solid environmental samples. Human specimens
can be drawn from whole blood, urine, vaginal, anal and nasal swabs,
bone marrow, sputum, serum, plasma and cerebral-spinal uid.
Advanced ultrasonic techniques enable rapid lysing of all cell types.
small footprint:
Compact and self contained, GeneXpert can be installed in nonlaboratory settings. The GeneXpert Systems space-saving design
and low-power requirements make it possible for the system to be
installed and operate in virtually any indoor setting.

expert: for time-critical results

expert: in action

fast:
Built to give you the answers you need now. Waiting hours or even
days for lab results is history. With the GeneXpert Systems ability
to perform extremely rapid heating and cooling cycles, it can deliver
exceptionally accurate and consistent test results in as little as 30
minutes. This represents the shortest time-to-results of any system.

safe:
Self-contained, disposable cartridges increase safety. The single
use, sealable test cartridges come pre-loaded with all the chemical
reagents required for sample preparation. They are designed to
reduce the possibility of amplicon contamination or accidental
environmental discharge.

exible:
Congurable up to 16 modules, GeneXpert enables you to
perform multiple diagnostic tests simultaneously. Each of the
GeneXpert Systems modules can be individually and independently
operated. This unique capability enables users to conduct up to 16
different genetic detection tests concurrently. And because runs can
be started at different times, multiple operators can easily use the
GeneXpert System at the same time. This is ideally suited to timecritical situations where specimens need to be analyzed as they
come in, rather than in batches.
easy to use:
Automated diagnostic software eliminates interpretation. The
system software comes pre-installed on a desktop or laptop
computer and displays results for each module in real time as soon
as PCR is complete. Time to results is available by checking the
status indicator screen. Whether you need to run one or multiple
tests simultaneously, the GeneXpert Systems fully automated
software gives you highly accurate positive or negative results that
have been validated by extensive third-party scientic organizations
and/or governmental agencies.

accurate:
Four-channel optics gives you precise and consistent PCR results.
The GeneXpert System enables the detection of multiple unique
targets within a single cartridge (multiplex assays) with the use of
four-channel optics for uorescent detection. This enables highly
accurate and consistent results.
sensitive:
Integrated sample preparation and testing eliminates
contamination and increases sensitivity. By eliminating major
sources of internal and external contamination, the GeneXpert
System has a sensitivity capability of single cell detection,
making it potentially more sensitive than any other system on
the market today.

Specications
Optics

Physical dimensions

Dye detection limit < 2 nM for FAM/TxR

Optical channel characterization:

Processing unit: 11.5 w x 14 h x 12.25 d

As little as 2.5 linear feet of bench space

Channel
Excitation (nm)
Emission (nm)
Simplex Dyes
Multiplex Dyes

1
450495
510527
FAM

2
500550
565590

3
565590
606650

TET

TxR, ROX
TxR

Intercalating dye

FAM

4
630650
670750

Reaction site thermal controls

- Solid state heater and forced-air cooling at each site
- Reaction chamber thermistors calibrated to 0.50 C

using National Institute of Standards and Technology

(NIST)-traceable standards
- Up to 16 independently-controlled reaction sites

Power requirements
100240 VAC, 5060 Hz, 350 Watts

GeneXpert Diagnostic System U.S. Part Numbers*

GeneXpert 1 site starter system

GX1001N1-1

GeneXpert 1 site starter system

GX1001N3-1

GeneXpert 2 site starter system

GX2001N1-1

- processing unit with desktop computer

- processing unit with laptop computer
- processing unit with desktop computer

GeneXpert 2 site starter system

GX2001N3-1

GeneXpert 4 site starter system

GX4001N1-1

GeneXpert 4 site starter system

GX4001N3-1

- processing unit with laptop computer

- processing unit with desktop computer

Cartridges

- processing unit with laptop computer

Single-use disposable cartridges

Polypropylene construction

GeneXpert Biothreat System U.S. Part Numbers*

Performance parameters
Heating ramp rates (max.):
10 C/sec from 50 C to 95 C
Cooling ramp rates (max.):
2.5 C/sec from 95 C to 50 C
Temperature duration accuracy:
1.0 sec from programmed time
Temperature accuracy:
0.5 C from 60 C to 95 C
Melt curve programmable ramp rates:
0.1 C/sec to 1.0 C/sec

GeneXpert 1 site starter system

GX1000N1-1

GeneXpert 1 site starter system

GX1000N3-1

GeneXpert 2 site starter system

GX2000N1-1

- processing unit with desktop computer

- processing unit with laptop computer
- processing unit with desktop computer

GeneXpert 2 site starter system

GX2000N3-1

GeneXpert 4 site starter system

GX4000N1-1

GeneXpert 4 site starter system

GX4000N3-1

- processing unit with laptop computer

- processing unit with desktop computer
- processing unit with laptop computer

* For the full Cepheid product catalog and for international part
numbers, please visit www.cepheid.com
Practice of the patented polymerase chain reaction (PCR) process requires a license. The GeneXpert System is an authorized thermal cycler and may be used with PCR
licenses available from Applied Biosystems. Its use with authorized reagents also provides a limited PCR license in accordance with the label rights accompanying such
reagents. Purchase of this instrument does not convey any right to practice the 5 nuclease assay or any of the other real-time methods covered by patents owned or controlled by Roche or Applied Biosystems. Cepheids GeneXpert System is a licensed real-time thermal cycler under Appleras European Patent No. EP 0 872 562, Japanese
Patent No. JP 3136129 and patents pending, for all elds including human in vitro diagnostics except for diagnosis and monitoring of HIV and HCV infections.

CORPORATE HEADQUARTERS
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Sunnyvale, CA 94089
Toll-Free: 888.336.2743
Phone: +1.408.541.4191
Fax: +1.408.734.1346

EUROPEAN HEADQUARTERS
Vira Solelh
81470 Maurens-Scopont
France
Phone: +33.563.82.53.00
Fax: +33.563.82.53.01

www.cepheid.com
0112-02