Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System

Cepheid Receives CE Approval for New STD Assays on Their GeneXpert System

Improving patient outcomes is always the goal of molecular diagnostics. Our GeneXpert® family of systems has set a new standard in workflow flexibility, 24/7 testing accuracy, and user-friendly design-delivered in an astonishingly compact package.

But we’ve done more than just repackage a good thing-we’ve improved on the fit, form, and function of the most popular molecular diagnostic platform on the market.

GeneXpert System technology is the cornerstone of our unique approach to molecular diagnostics product suite, which allows us to offer a complete menu of tests on a single, fully scalable, consolidated workstation.

The GeneXpert System is available in a one, two, four, or 16-module configuration. All have our proven GeneXpert module at their analytic heart, and use the same patented cartridge technology for every

Xpert® test.

Diagnostics on hyper-drive.

When it comes to speed, other molecular analyzers simply can’t compete. The GeneXpert System returns most test results in about an hour, including sample prep! Our systems deliver results even faster than many alternative technologies, such as EIA or Immunoassay.

With the GeneXpert technology, labs no longer need rows of equipment and extensively trained staff to access molecular testing. No matter which GeneXpert System you choose, Cepheid’s technology makes on-demand molecular testing available to everyone-with unprecedented speed and ease-of-use.

Our patented cartridges also deliver unsurpassed accuracy across the broadest possible menu, and are virtually unlimited in the sample types they can process.

Compact size, giant ability.

With its compact design, the GeneXpert System allows for portability in the field and can run tests just about anywhere. In fact, due to the recent World Health Organization (WHO) endorsement of our systems, we now have molecular diagnostic “centers of excellence” in some of the most remote places on earth.

The decreased system footprint and consolidated testing design creates space-saving efficiency, reducing the need for multiple testing platforms. These new systems are also designed to be stackable, for those labs where space is a particular issue.

And we’ve now introduced a new configuration, the two-module GeneXpert System, to provide even more options for smaller institutions.

More horsepower under the hood.

Underneath the clean lines of the system exterior, components have been reconfigured to further reduce the system footprint.

These revised components, including larger fans, also helps these new systems to run cooler and quieter—which means the most reliable molecular systems on the market just got even more so.

But the heartbeat of our technology—the patented cartridge and module—remains unchanged. You can count on all current and future tests running on any generation of GeneXpert System.

Tuberculosis is still a huge global health problem, with the most frightening part perhaps being the multi-drug resistant strains of the mycobacterium. One obstacle which has hampered effective control of this disease, especially in poor countries, is the long time it takes to diagnose it. In these lower-income areas, the standard diagnosis of TB is by microscopy, but this does not give any information on drug-resistance – those cell culture tests take two weeks, by which time it might have spread to many other people.

A Swiss group, The Foundation for Innovative New Diagnostics, has come up with a better way. The sputum sample is first treated with sodium hydroxide and alcohol, killing any TB, and the sample is fed into a small device which analyzes the DNA and gives a simple report regarding the presence of TB and the resistance status of the organism. This shrinks the time-frame for diagnosis of multi-drug resistant TB from 2 weeks to 2 hours. The individual tests cost only $17, although the machine costs $17,000. This is a nice example of cutting-edge technology being scaled to low-cost applications in resource-poor areas.

Cepheid, Sunnyvale, CA, received CE approval for a new infectious diseases assay on their GeneXpert system. The new assay enables rapid detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). The GeneXpert works with disposable, single-use cartridges that hold the sample and reagent in a small processing chamber. Many assays are already available like the MRSA, enteroviruses and Group B Streptococcus cartridges.

GeneXpert cartridge Cepheid Receives CE Approval for New STD Assays on Their GeneXpert SystemThe GeneXpert itself is a closed, self-contained and automated platform. It combines on-board sample preparation with real-time PCR amplification and detection functions for nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences and comes in a one, two, four, or 16-module configuration.

John Bishop, Cepheid’s Chief Executive Officer is cited in the press release:

“We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability. We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients the critical first step in effectively managing these diseases.”

Source : http://www.cepheid.com/systems-and-software/genexpert-system

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