Healthcare Industry News: IPLEX
News Release - January 7, 2008
Cepheid Begins Shipment of Next Generation GeneXpert(R) Molecular Diagnostic SystemsHardware and software enhancements to the GeneXpert(R) System follow strong fourth quarter system placement momentum
SUNNYVALE, Calif., Jan. 7 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ) today 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 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.
All current GeneXpert-based tests, including Xpert(TM) 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.
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 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. By eliminating manual entries and paper-based workflows, the new GeneXpert
Systems improve the efficiency of transactions and may reduce the chance of transcription errors. Software upgrades are available to existing customers.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD ) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to product performance and future market opportunities. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen manufacturing problems; customer and market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2006 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
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