New Capabilities Will Further Extend GeneXpert System Technology Advantages
SUNNYVALE, Calif., June 10 /PRNewswire-FirstCall/ -- Cepheid today announced that it has received a notice of grant award from the National Institute of Allergy and Infectious Diseases to develop new ten-color detection technology for use in its GeneXpert(R) System. The $7.5 million grant will be awarded to Cepheid and the University of Medicine and Dentistry of New Jersey (UMDNJ) during the planned five-year program. When coupled with Cepheid’s virtual array technology, the new ten-color system will have the potential to simultaneously detect up to 100 different targets per sample. Cepheid’s current GeneXpert System is capable of six-color detection, with the potential for up to 60 different targets per sample.
“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 John Bishop, Cepheid’s Chief Executive Officer. “Existing GeneXpert System accounts will also be able to benefit from the expanded test menu that this program should enable.”
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 David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “A ten-color cartridge, in combination with our virtual array technology, gives us the ability to detect as many as 100 distinct targets in a single test. This feature eliminates the need for guesswork, and when performed on the GeneXpert System, will help deliver cost-effective, medically actionable results to clinicians and their patients.”
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 David Alland, M.D. “This dramatic increase in the number of targets we can detect with a single test will enable us to develop an assay for MDR and XDR Mycobacterium tuberculosis that will give clinicians a full panel of information, including resistance to the widest variety of treatments.”
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.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests 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, 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.
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.
CONTACT: Media, Jared Tipton, +1-408-400-8377, jared.tipton@cepheid.com,
or Investors, Jacquie Ross, +1-408-400-8329,
investor.relations@cepheid.com, both of Cepheid
Web site: http://www.cepheid.com/
