Cepheid Receives Grant to Develop Ten-Color Real-Time PCR Detection Technology for Use in the GeneXpert(R) System
New Capabilities Will Further Extend GeneXpert System Technology Advantages
“This program will be primarily driven by our special chemistry capability which, along with software development, is expected to allow for completion of the program with no hardware modifications,” said
The new ten-color technology is expected to deliver more cost-effective infectious disease panel testing applications by increasing the total number of diagnostic results per sample. The technology will also enable the development of new, comprehensive antimicrobial resistance and oncology tests.
“The workup of many infectious conditions requires considerable guesswork on the part of clinicians, who typically order multiple individual tests for suspected etiologic agents,” said
Building upon the success of Cepheid’s six-color Xpert(R) MTB/RIF test, clinical utility of the ten-color system will be demonstrated through development of a new assay for multidrug-resistant (MDR) and extensively drug-resistant (XDR) Mycobacterium tuberculosis (MTB). Future GeneXpert-based tests, which apply the ten-color technology, are expected to follow.
“Our goal is to continue the transformation of the clinical mycobacteriology laboratory by making it possible to replace time-intensive and less sensitive culture processes with rapid, sensitive, and accurate molecular techniques that that are not constrained to a central laboratory environment,” said UMDNJ’s
About the GeneXpert(R) System Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.
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, future products 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; uncertainties inherent in the regulatory process; regulatory developments and changing practices regarding testing; customer and market acceptance of the product; pricing of any new products; 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; uncertainties related to government funding; and the uncertain impact of the global economic downturn. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K for 2008, filed with the Securities and Exchange Commission.
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