SUNNYVALE, Calif., May 15 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced the European release of the Smart EBV(TM) (Epstein-Barr Virus) Assay for clinical diagnostic use on the SmartCycler(R) System. The EBV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart EBV is intended for rapid detection and quantitation of EBV viral load. EBV infection is associated with development of post-transplant lymphoproliferative disorder (PTLD), a serious complication of bone marrow or solid-organ transplantation in which uncontrolled growth of lymphatic tissue can become life-threatening. EBV related disease is also common in immunocompromised patients such as those with HIV/AIDS. These conditions can be fatal if they are not diagnosed, treated, and subsequently monitored on a periodic basis.
"Immunocompromised individuals are at high risk of developing B-cell lymphoproliferative disorders, ranging from benign B-cell proliferations to malignant lymphomas, known as PTLD. EBV reactivation, usually causing these B-proliferations, is demonstrated by measuring the viral DNA load in the peripheral blood," said Dr. Jean-Marie Seigneurin, Professor of Virology, Faculty of Medicine, University of Grenoble, in France. "EBV quantification by real-time PCR permits an early diagnosis in the course of disease, in order to initiate a treatment for reducing the risk of PTLD."
"Following the successful European launch of tests for Group B Streptococcus and BCR-ABL, Smart EBV is Cepheid's third clinical molecular diagnostic product with CE Mark certification for introduction in Europe this year and is the first in a planned series of products targeted for the management of immunocompromised patients," said Cepheid Chief Executive Officer John Bishop.
EBV is a major risk factor in immunocompromised patients such as those with AIDS, bone marrow transplant recipients, or solid organ transplant recipients. Viral load monitoring is important in optimization of therapeutic intervention. EBV has also been implicated in other benign and malignant disorders such as infectious mononucleosis, Hodgkin's disease, non-Hodgkin lymphoma and nasopharyngeal carcinoma. Patients with EBV related diseases often present with high levels of EBV in blood cells, serum or plasma which can be tracked over time. The Smart EBV assay offers a standardized method that can be used with all three of these types of specimens offering a wide dynamic range and highly sensitive limit of detection. The use of an internal control greatly reduces the risk of false negative test results.
The SmartCycler(R) System is a leading real-time PCR testing platform for hospitals, university research labs and government agencies. By automating the amplification and detection process, the SmartCycler(TM) System can deliver highly accurate and consistent test results from prepared biological samples in approximately 30-40 minutes. With up to 96 independently programmable reaction sites, the SmartCycler can simultaneously run multiple experiments with different protocols and at different times. This eliminates complex advanced scheduling on larger, more costly systems as well as the need to transport samples to central facilities for analysis.
About Cepheid
Cepheid , based in Sunnyvale, Calif., is a 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 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 timing of future product releases. 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: uncertainties relating to regulatory processes; unforeseen manufacturing problems; the performance and market acceptance of 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; 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 2005 and its other reports 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.
CONTACTS: At the Company: John L. Bishop John R. Sluis CEO, Cepheid CFO, Cepheid 408-541-4191 408-541-4191 john.bishop@cepheid.comjohn.sluis@cepheid.com At Financial Relations Board: At Schwartz Communications: Tricia Ross Chris Stamm / Tom Bain Investor/Analyst Information 781-684-0770 617-520-7064 cepheid@schwartz-pr.comtross@financialrelationsboard.com
CepheidCONTACT: John L. Bishop, CEO, john.bishop@cepheid.com, or John R. Sluis,CFO, john.sluis@cepheid.com, both of Cepheid, +1-408-541-4191; or TriciaRoss, Investor/Analyst Information of Financial Relations Board,+1-617-520-7064, tross@financialrelationsboard.com, for Cepheid; or ChrisStamm, or Tom Bain, both of Schwartz Communications, +1-781-684-0770,cepheid@schwartz-pr.com, for Cepheid
Web site: http://www.cepheid.com//