Cepheid launches GeneXpert molecular diagnostic system

16 January 2008

Cepheid (NASDAQ:CPHD) has begun shipment of its next generation GeneXpert self-contained automated molecular analysis system.

The system uses real-time polymerase chain reaction (PCR) to amplify and detect target DNA. It automates and integrates all the steps required for PCR-based DNA testing: sample preparation, DNA amplification and detection. It provides PCR test results from a raw sample in 30 minutes or less, enabling time-critical DNA tests at the point of need.

The entire GeneXpert family of systems feature six-colour 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 US 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-colour optics capability enables advanced multiplexing, making it possible to detect more molecular targets within a single test cartridge. The unique 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.

Reflex testing is particularly important in clinical applications where results can guide treatment decisions, such as for the detection of infectious disease where the first reaction tests for the organism and the reflex test identifies the specific strain susceptible to drug resistance.

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

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