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.
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
"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.