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Cepheid Begins Shipment of Next Generation GeneXpert® Molecular Diagnostic Systems

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Cepheid has announced that the Company has begun shipment of next generation GeneXpert® Systems. The entire GeneXpert family of systems, including the new single module system GX-I, will now feature six-color optical capability that will enable detection of up to 60 individual targets in a single cartridge.

The systems will also feature new software that enables Laboratory Information System (LIS) integration capabilities, linking any GX-I, GX-IV and GX-XVI System to healthcare institutions' central database for receiving, processing and storing test results.

The release of these enhancements follows a strong fourth quarter performance that saw 125 diagnostic GeneXpert System placements in Europe and the U.S. during the quarter. The system placements were comprised of 783 GeneXpert module installations.

"These new system enhancements are expected to further increase the utility of the GeneXpert System in processing data output and in achieving a high level of multiplex testing, which will be applied to infectious disease and oncology diagnostics," said Cepheid CEO John Bishop.

"Additionally, these enhancements are expected to provide long-term benefits as our menu of tests grows, from infectious disease testing through oncology, and into broad-based genetic disease testing."

The new GeneXpert System six-color optics capability enables advanced multiplexing, making it possible to detect more molecular targets within a single test cartridge. The configuration of the GeneXpert cartridge allows for two reactions per test, which means that a total of 60 targets will be possible.

The two-reaction capability also allows for reflex testing, in which the first test result indicates and automatically initiates a second related and potentially necessary diagnostic test.

All current GeneXpert-based tests, including Xpert™ MRSA, are compatible with the new six-color modules. Additionally, existing customers can expand their current GeneXpert Systems with the new six-color modules by adding to, or replacing, their four-color modules. The GeneXpert System software is capable of managing both four-color and six-color module types within the same GeneXpert System configuration.

GeneXpert Systems also include GeneXpert® Software 2.1, an application that synchronizes test data between any GeneXpert System and LIS. Upon completion of a test, the GeneXpert System may automatically upload test results to the LIS, providing healthcare professionals with results as soon as they are available.